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MedSun KidNet Roundtable Discussion (2007)

PDF Printer Version15 October 2007


Slides

 KidNet most frequently reported devices by device type

  • Report received from MedSun KidNet sites with patient ages listed as <21 years
    6-1-2007 to 9-25-2007:
    n=42
  • IV Products n=17
    • IV tubing, filters - 6
    • IV pumps (large volume, syringe) - 5
    • IV catheters (short term) - 3
    • VCs, PICCs and Ports - 3
  • Surgical Products n=11
    • Orthopedic screw - 2
    • Spinal system hardware - 1
    • Intraventricular shunt - 1
    • Laryngoscope handle - 1
    • OR table - 1
    • Surgical blade - 1
    • Hydrosurgery handpiece - 1
    • Dissecting forceps - 1
    • Microscope, ENT - 1
    • Guidewire, biliary - 1
  • CV Products n=10
    • Pediatric ECG electrode - 6
    • ECMO pump - 2
    • Septal Occluder - 1
    • Pulmonary valved graft conduit - 1
  • All others n= 4
    • Nebulizer - 2
    • Crib - 1
    • Echocardiography-Ultrasound - 1

KidNet - top 2 reported devices

  • A note about our the types of reported problems for IV products and pediatric electrodes

IV Products

  • Reported catheter and port problems include cracks in hubs, disconnection of filters, cracks or disconnections in ports, bent needles, and a PICC line severing below the stabilizing wings.
  • Reported IV tubing problems– disconnections, leaks (at the hub), fluid delivery issues (fluid backing up into the primary bag), and packaging (one set had no tubing in it when opened).
  • Recent reported problems with pumps include fluids being infused too rapidly or not at the programmed rate, or the pump spontaneously shutting-down.

IV Products – Recent Successful follow-up

Syringe Infusion Pump

  • A report described a pump failure whereby the motor shut down when the patient was walking outdoors in the sunlight under nursing supervision. The reporting hospital indicated the pump manufacturer had identified a defect causing the motor to shut down in extreme sunlight, which could be corrected by installation of a shield over the motor case. FDA follow-up with the manufacturer resulted in the manufacturer sending a letter to all customers asking them to obtain an update kit with a shield or to return these pumps to the manufacturer for retro-fitting.

Syringe Pump

  • A pediatric patient was found holding a syringe of medication, while standing in the patient’s crib. The syringe of medication had been properly placed in the syringe pump, even though the patient was able to pull on the tubing, reaching the syringe and removing it from the pump. Follow up with the manufacturer indicated that although the event was the only reported issue of this type at the time; a lock box was being created to prevent this issue from reoccurring.
  • Before the manufacturer was able to get the lock box mechanism out again, another report of the same thing happening was received from a KidNet hospital this past summer. Our follow-up with the manufacturer was that the manufacturer had been working on it, but the new lock box wasn’t complete yet. But by getting the second report on this pediatric syringe pump with the same problem, with a different patient, the manufacturer is now moving forward more quickly.

Pediatric ECG Electrodes

  • It was reported to MedSun:
  • During a routine assessment it was noted the electrodes were sliding off. Upon removal of the electrodes, small bumps were found on the chest and stomach where the electrodes had been placed. The chest bumps were reddened and one was blistered. The stomach bumps resembled pimples. 6 reports of this problem were reported from a single facility.
  • Follow-up with the manufacturer indicates they have had other similar reports. In those cases, the person who attached the electrodes had lotion or an emollient on their hands that had gotten trapped between the electrode and the infant's skin and caused a chemical reaction. In this case, they have been analyzing the electrodes and, so far, have not found anything unusual, but they are continuing their evaluation and analysis.
  • The manufacturer has told us that an update will be sent on their progress.

Recently Received Medical Device Adverse Events

  • Ventilator water trap
  • Infant warmer mattress

Ventilator Humidifier Water Trap

  • As reported to MedSun:
    Prior to this incident, the ventilator circuitry had just been changed. The sterile water bag had just been spiked to fill the heater/humidifier water chamber. The float in the water, which controls the water level was stuck. This caused the water to fill the water chamber and flow up into the circuit to the patient, causing a 51 day old patient to de-saturate, and become bradycardiac and cyanotic. The patient was immediately taken off the ventilator and manually ventilated until full recovery, and the water chamber was replaced. According to the hospital’s respiratory therapy department, this type of failure is not easily identifiable until the sterile water is added to the circuits, which generally occurs after the patient is on the ventilator. Additionally, depending upon the speed and nature of the defect, it may take anywhere from seconds to hours for the water to fill the heater chamber to a level that will direct water toward the patient. 
  • MedSun follow-up with the site reporter indicates:
  • The manufacturer’s quality team has received the hospital’s report.
  • It took less than 5 minutes for the water to fill the heater chamber in the reported incident.
  • This exact problem seems to happen once a year or once every other year. As a new risk manager, not sure why this hasn’t been reported previously.
  • The hospital doesn’t think the ventilator circuitry is defective and there are no alarms/alerts to notify staff if the heater overfills – heaters don’t have that as an option. There is a a high pressure alarm.
  • Have you seen this, or a similar problem?

Infant Warmer Mattress

  • Extremely low birthweight infant, born by vaginal delivery with Apgars of 5 at one minute 8 at 5 minutes was delivered and placed on a seated transport Isolette on a infant warmer mattress infant transport mattress, shown to the mom, and wheeled down the hall to the NICU for admission. At that time, the patient was hypothermic with a temperature of 35°C. The infant warmer mattress from the delivery room was placed under the infant when the infant was moved from the transport Isolette to the radiant warmer. The infant was on the radiant warmer for approximately 3 hours following admission. Subsequently, the patient was moved from the radiant warmer to an Isolette without the infant warmer mattress. At the change of shift, nursing staff noted what was thought to be an abrasion on the infant’s lower back. Later, the area became more clearly demarcated as a 51/2 cm x 3 cm reddened area with a small open area in the lower aspect. It was diagnosed as a 2nd degree burn. A physician assessed the burn and prescribed Bactroban ointment 3 times a day. The burn completely healed without any escalation of care and no skin grafts were required.
  • Additional information about the event from the reporting hospital:
  • The event was reported voluntarily because no one at the reporting hospital has ever observed any issues with this product, which is used extensively for neonate after delivery for transport purposes.
  • The manufacturer's instructions are that this device will warm to 40°C once the Silver disk is compressed. The unit manager re-created the scenario after the event. She was able to obtain temperature ranges between 40.2°C and 40.6°C taken with the temperature probe beneath the infant warmer gel pad and the mattress, and also on top of the infant warmer mattress patient side surface and the radiant warmer head. It took about five minutes for the device to reach the range of temperatures listed. The patient was placed correctly on the infant warmer mattress patient side surface. 
  • Labeling review for the device found the peak temperature of the pad is dependent on the starting temperature of the pad itself.
  • Have you seen or experienced this, or a similar problem?
  • A comment forwarded from a MedSun site was then shared about transport isolettes with battery packs not holding their charges. All of the isolettes needed to have the packs replaced.
  • A MedSun Representative (a clinical engineer) from a pediatric hospital offered to be a resource to others having this difficulty.  Those who are interested in the battery issue should contact tpowell@s-3.com for more information about how to reach this MedSun Representative.

Peds ICU Monitor

  • A device safety issue recently called in to us by a MedSun hospital:
  • Problems with being “unable to zero- unstable signal” with monitors in a Peds ICU. During the set up procedure using a MMS (multi-measurement server) but not using an invasive blood pressure module, the monitors experience an alarm/alert message “unable to zero - unstable signal. The staff believes that this condition should not be occurring during a procedure set up. The manufacturer has been out to the facility on more than one occasion and has witnessed this happening.
  • Do you think this is an equipment (materials, or sensitivity to readings), a procedural issue (zeroing technique), or a patient issue (related to patient movement or size)?
  • Have you seen or experienced this, or a similar problem?
  • Discussion about specific human factors concerns with the display on specific patient monitors indicated that extensive staff re-training was needed. The MedSun Representative from the pediatric hospital bringing this safety issue to the Roundtable (a clinical engineer) offered to be a resource to others having this difficulty. 
  • Those who are interested in the further discussion on this hospital’s actions taken to resolve the problems related to zero-ing ICU monitors on set-up should contact tpowell@s-3.com for more information about how to reach this MedSun Representative.

 Complete Transcript

A total of 18 people from 10 hospitals participated in the one hour MedSun KidNet Roundtable Discussion teleconference that was held on Monday, October 15th, 2007.

SPEAKERS

Dr. Jacqueline Francis
Suzanne Rich
Tina Powell

PRESENTATION

T. Powell: My name is Tina Powell. I’m Project Director for Planning, Hospital Communications and Special Studies for the MedSun project at Social and Scientific Systems, Inc. which is a contractor to the FDA for this project.

Today, we’re having our first KidNet roundtable to talk with pediatric and neonatal staff at MedSun sites around the country. We’re going to talk about FDA’s role in patient safety, having to do with devices that are used in PICUs and NICUs. We’re going to get more and more specific as the call goes on, talking about some of the kinds of reports that FDA has received, and then some of the specific problems that have been reported recently.

Our speakers today are Jacqueline Francis, who is a physician and has a Masters in public health. She’s a medical officer at FDA’s Center for Devices and Radiological Health. She’s been working for FDA for three years. In addition to her work here, she worked in two local hospitals, Georgetown Hospital and Sibley Hospital, as a pediatrician.

Our other speaker today is Suzanne Rich, who is a registered nurse and also has a Masters degree. She is project manager at the FDA’s Center for Devices and Radiological Health and has over 20 years of experience with review of adverse event reports having to do with medical devices and review of situations indicating potential for harm.

I’m going to start off today with a welcome from Dr. Francis. Thank you, all, for being on the call. Later on the call, I will get back with you, a wrap-up and some next steps, but today’s session is going to be very conversational. So we will be opening it up to your questions and your comments as the session moves along. There will definitely be times when we’ll be asking for you to participate. So think of this as if you were here with us in this meeting room here at FDA, talking about your concerns when it comes to medical devices affecting children. Dr. Francis?

Dr. J. Francis: Good afternoon. Welcome, again, to the first MedSun KidNet Roundtable Discussion for Pediatric and Neonatal Staff on the FDA’s Role in Product Safety. As Tina mentioned, my name is Jacqueline Francis and I’ll be your moderator for today’s discussion.

I believe that I speak for the patient safety staff and NSSF when I say that we’re very excited for the opportunity to interface and discuss directly with you, our KidNet participants, on current medical device related issues. We hope to continue to conduct our roundtable discussions like this on a quarterly basis, thus providing ongoing communication and feedback between your staff and ours.

So now, Tina is going to go over an overview of the format today and our agenda.

T. Powell: Okay. Thank you. We’re going to have Suzanne Rich talk about a brief summary of the numbers and types of reports that have come in since June from the sites that are participating in KidNet. Now, these are not limited to reports that have come from PICUs and NICUs, but they’re broader than that. They’re about pediatric patients and they’re from the sites that are currently on board.

I know some of you are already participating in KidNet. You’ve had clinicians from your NICUs and PICUs go through our orientation sessions and others of you are considering whether to join the project. We will be following up with all of you after this call, to see if you would like to, if you haven’t already, to have people go through a Webcast orientation session, so that they may report for the MedSun site about problems that are seen in PICUs and NICUs.

After that, we’ll be talking about some steps that reports go through when they are received at FDA, what happens to the reports as they are reviewed here, and getting into some very specific examples of events that have been reported to FDA in recent months.

So with that in mind, I’m going to turn it over to Suzanne Rich.

S. Rich: Good afternoon. We’re very excited about this roundtable. Well, let’s get started, and let me tell you that we have received about 42 reports since we started collecting data under the KidNet umbrella. Keeping in mind, of course, MedSun has been around at least since 2002 in its present form. But our KidNet data collection began June 1st and we have about 42 reports. About one-third of these represent events that are occurring in the NICU and the PICU. The other two-thirds are associated with reports involving pediatric patients in various settings throughout the hospital.

About one-third of these reports involve patient injury and about two-thirds represent potential for harm. Those are the gems for us and are actually our hallmark. MedSun’s hallmark is getting adverse event reports that represent a potential for harm, so that we at FDA can be alerted and work with you and our medical device community (manufacturers, clinical professional organizations, and other state, national, and global government agencies), to try to solve problems before we get injuries.

That being said, the top reported three event areas or clinical specialty areas that we receive reports on, are in the IV, surgical and cardiovascular product areas. That probably doesn’t surprise too many of you. Out of the IV products, most of our reports have come in on IV tubings and filters. Those typically involve cracks, disconnects and leaks, followed by IV pumps where we’ve had some reports of large volume and syringe pumps. These reports typically involve programming problems or over infusions.

In the surgical device area, it’s been quite interesting. The IV products represent about 17 reports out of the 42. We’ve gotten 11 reports on the surgical devices and they’re scattered all over the arena, which again, we found quite interesting. Two reports of failures of orthopedic screws came in and I think we received the two reports for the one event simply because there were two screws used for the one patient. Other products that we’ve received reports on in include a surgical blade, an OR table failing to maintain position, and a hydrosurgery handpiece overheating.

In the cardiovascular device arena, we’ve received six reports from one facility on pediatric electrodes, which we’ll be discussing a bit later, two on an ECMO pump and two others on cardiovascular interventional devices. Then we have of what I call stragglers, but important nonetheless. We have two reports on nebulizers and, of course, one on a crib, and one also on an echocardiographic ultrasound problem involving a software issue.

So what happens to these reports when they come into FDA? They first get submitted by either you, the front line KidNet person, or if you’re a risk manager, and they come into our computer database whereby our contractor, Social Scientific Systems, actually screens them for completeness, to make sure that all the data fields are filled out, and we try to get as complete an event description as possible.

Sometimes you’ll have gotten, or will get, calls from the folks at Social and Scientific Systems. These folks are clinicians just like you, nurses, and biomedical engineers that have recent clinical experience and triage the reports, much like our emergency room nurses and doctors triage patients as they come in.

Once the reports are entered, they’re then reviewed in terms of actual and potential risk for public health. Things that look like they are significant are sent, and we are alerted here in FDA to bring to our attention, so that we can get some actions started in terms of follow-up, perhaps, with you or the medical device manufacturer, or we’ll get started on some of our internal investigation (including checking for similar reports, reviewing device labeling, doing a literature search for similar reported problems) right away. By and large, those are the minority. Those are more infrequent than frequent. Most reports we receive represent problems of significance, but certainly not something that warrants an immediate intensive follow-up.

What happens in order for us to be able to more completely and accurately put reports that don’t require immediate follow-up into perspective in light of the fact that we’re receiving about 50 or so reports from all MedSun sites per week? These reports are reviewed in a group with SSS (Social and Scientific Systems) clinical staff, and our FDA specialists. These specialists include reviewers of the medical device adverse event reports, as well as physicians, human factors, specialists and other engineers to take a look at what the significance might be of the individual reported event and also to try to put it in perspective of other previously reported events.

Once we get the report triaged in terms of immediate versus a more routine follow-up, the reports are sent over to FDA’s medical device adverse event report review group. That’s our product evaluation branch. These are reviewers, again, many of which have had clinical experience and include physicians, engineers, chemists, biologists, etc.

The first thing we do as medical device adverse event reviewers is to go back into the adverse event report database and see whether or not we’re seeing any reports on a similar device by that manufacturer, with that model. If we don’t see any of those, we may go in and look for similar types of reports on that type of problem with manufacturers of similar products. We go back and look at the labeling to see if it looks like it might be a use issue. We may do some literature searches and reviews to see what other problems may have been reported and some solutions that may have actually been reported.

Sometimes we call you back because we’re not quite clear exactly about some of the particulars. It’s not that we call you back because the quality of the report is poor. In fact, nine times out of ten, they’re good reports. We end up getting so much information, that we may want to get a little bit more to really flush specific details of a reported event. Your input and follow-up on these calls are very, very helpful.

We also work with our manufacturers and we give them a call and say, “This type of report has been submitted. These are some of the details that we found. What have you found on your evaluation?” Sometimes there are some peculiarities with a certain reported scenario and we explain that to them. They work with us and they tell us what they’ve seen in terms of what’s been reported to them on a similar complaint, and what they think the problem is. We try to come to some kind of consensus for a solution strategy to work on determining the etiology of a reported problem if it’s not immediately apparent.

Sometimes, MedSun reports that we’ve received have actually been on the cutting edge of an emerging problem. So, the fullness and the richness of detail that you, as reporters, provide on these potential for harm events is critical. When reports are received on something that could happen based on potential for harm, it really leads manufacturers to go back in and say, we thought we might have seen a trend on this. But now, this is really helping us to kind of put some of the pieces together.

So let me talk with you a little bit about some of the products that we have received, meaning the reports on products that we’ve received since the beginning of June. I’m going to focus on the two top areas. One is on the IV products and one is on the pediatric electrodes. These are common devices. I know you’re probably thinking, “Well, these are normal. We would expect reports on these.”

What we find on these reports is that with a couple of these, that even on something as simple as cracks in a hub or a disconnection of a filter, we’re able to work with the manufacturer to address the problem. A lot of times, if it’s a simple manufacturing problem, the manufacturers may be able to go back and either retrain device operators on the manufacturing line or make other manufacturing process changes. Or perhaps they have to go back and redesign the device to make it more user friendly or durable, or make changes in the instructions for use so users know how to properly use the device.

But the IV products that we’ve received since June, we’ve had reported catheter and port problems. A couple of the IV tubing problems that we’ve had with the disconnections and the leaks have to do with just making sure (although some of this is basic and I’m not trying to question anyone’s professional integrity), but sometimes, it has to do with the method that folks use in getting these devices connected, as well as possible device design or integrity issues. Sometimes we have fluid delivery problems, and we’ve had several reports of fluid backing up into the primary IV solution bag.

For example, come to find out, believe it or not, on a couple of reports, we found out that the piggyback bag was not being elevated, so that it’s above that primary IV tubing bag. It sounds very simple and very basic, but when we’re rushed and hurried and pushed as caregivers, sometimes we forget.

We did get a report of a packaging problem where we had an IV tubing set that had no tubing in it; that’s a problem that we are following up with the manufacturer.

We had a couple on programming rates where the fluid was not being delivered at a rate at which it was being programmed. We’ve had one interesting report of a pump, an IV pump, spontaneously shutting down. This is a large volume IV pump. This pump had been programmed to deliver some cardiac resuscitation drugs at a rather rapid rate. Unfortunately, the pump spontaneously shut down during the code on a patient. That’s not a good thing at all. We are following up on this.

As we speak, we have had some recent successful follow-ups on some IV products. These were not KidNet reports, but these were adverse event reports that we’ve received within the last four to six months. And one of which I thought was interesting in order to illustrate the point that even if you don’t think that a medical device adverse event problem is due to the manufacturer of a device, or solely to the device - if it has to do with perhaps a device-user interaction with the way you’re using it or that the patient’s using it, or the environment the device is being used in, that’s important. Report it to us.

Here’s the example report – a report where we had a pump failure whereby the motor shut down when the patient was walking outside in the sunlight under nursing supervision. This patient was looking forward to that day, to be able to go out. The patient started walking outside and the pump shut down - the patient was not harmed. The reporting hospital in this report indicated that they then learned the IV pump manufacturer had identified a defect that caused the motor to shut down in extreme sunlight, which could be corrected by installation of a shield over the motor case.

Well, what had happened is that it appears that not everyone had gotten that information, including this hospital. By this hospital reporting this to us, we were able to work with the manufacturer to make sure all of their folks who had purchased these pumps received that information.

We had one report on a pediatric syringe pump. It was late last year and the problem with that pump was that we had an event reported to us whereby a toddler was able to get the syringe out of the pump. The patient was found with the syringe in his hand. After getting this report, we started working with the manufacturer and the manufacturer indicated that they were working on putting a lock box mechanism on it and that they should be able to get that out very soon.

Before the manufacturer was able to get the lock box mechanism out again, we got another report on the same thing happening from a KidNet hospital this past summer. Our follow-up with the manufacturer was that the manufacturer had been working on it, but the new lock box wasn’t complete yet. But by getting the second report on this pediatric syringe pump with the same problem, with a different patient, the manufacturer is now moving forward more quickly.

That’s it for the IV pumps. Let me just briefly walk you through the pediatric ECG electrodes and then I was going to ask if we could get some feedback, but not yet. The ECG electrodes - we had gotten actually six reports whereby skin irritation noted on the chest and stomach where electrodes had been placed. We’re thinking that it is not uncommon with electrodes to get some of these irritations and some skin problems, but what was interesting to us is that we received six reports from one site. We don’t typically get six reports on the same problem with the same device from the same site.

So we followed up with the manufacturer. Sure enough, the manufacturer had other similar reports. What happened is that their investigations on these types of complaints indicate that a lot of times, it has to do with the emollient or the lotion that staff are using on their hands, and they think that might be the problem. Rather than just close it at that point and just leave it as a use problem, they are actively looking at other reports. And they are trying to put together some pieces to see if there are other commonalities. One of our medical device adverse event reviewers has indicated that the manufacturer is going to give us an update, once they have something back that they can share with us.

Now, that being said, I’d like to open it up to see if anyone has any comments about any of the information that I’ve shared with you thus far in terms of the reports that we’re received, any of the IV products and if you have any comments about the electrodes. If not, then we’ll move on. But please, if you have some comments, I think we’re ready.

S. Rich: It sounds like this doesn’t surprise you, the type of problems that have been reported with IVs and electrodes. Does anybody have any comments or anything else they’d like to share on these products?

S. Rich: Okay. Good enough. Well, let’s get into some of our more recently received medical device adverse events where we’re really looking to you for some of your feedback. Jackie?

Dr. J. Francis: Okay. I’m actually going to be reading some of the reports that we’ve actually received. As Suzanne mentioned, if after I read through the reports, if there are any comments or questions or concerns related to these devices, please let us know.

In particular, the first report is a ventilator humidifier water trap and it was reported to MedSun. The report states, “Prior to the incident in question, the ventilator circuitry had been changed and the sterile water had been spiked to fill the heater humidifier water chamber. The float in the water, which controls the water level, was stuck and this caused the water to fill the water chamber, to flow up into the circuit, to the patient, causing the 51-day-old patient to desaturate, become bradycardic and cyanotic. The patient was immediately taken off the ventilator, manually ventilated until fully recovered and then the water chamber was replaced.”

According to the hospital’s respiratory therapy department, this type of failure wasn’t usually identifiable until the sterile water had been added to the circuit and that generally didn’t occur until the patient was already attached to the ventilator. Additionally, depending on the speed and the nature of the defect, it may take anywhere from seconds to hours for the water to fill the chamber to the level where it would actually directly go towards the patient.

MedSun followed up with the site reporter and that follow-up indicated that the manufacturer’s quality team had received the hospital’s report. Apparently, it took less than five minutes for the water to fill the water chamber in the instance that I just described to you. This exact problem seemed to happen actually once a year or every other year.

The hospital didn’t seem to think that the ventilator circuitry was defective. However, there were no alarms or no alerts to notify the staff of the heater overfill. There was, though, a high pressure alert.
Apparently, the FDA is working on following up with this matter and the follow-up is ongoing. But we’d like to know from you, have you seen this or any similar problems?

Dr. J. Francis: Okay. Well, it sounds as if this isn’t necessarily anything new or exciting. So let me continue on. Again, please let us know if this next case report sounds familiar or concerning as well.

The next report involves an infant warmer mattress. “An extremely low-birth weight infant that was born by vaginal delivery with … at five and eight was delivered and placed on a seated transport isolate on an infant warmer mattress and infant transport mattress, shown to the mother and then wheeled down the hall to the NICU for admission. At that time, the infant warmer mattress from the delivery room was placed under the infant when the infant was moved from the transport isolette to the radiant warmer.”

“The infant was on the radiant warmer for approximately three hours following admission. Subsequently, the patient was moved from the radiant warmer to an isolette without the infant warmer mattress. At the change of shift, one of the nurses noted that there was what she’d thought to be an abrasion on the lower aspect of the patient’s back. That later was observed to be a clearly demarked five and a half centimeter by three centimeter rim area that was diagnosed by the physician on staff as a second degree burn.”

“The burn was treated with Bactroban three times a day and the burn completely healed without escalation of care and no skin graph was acquired.” Additional information about the event from the reporting hospital revealed that the event was reported voluntarily because no one at the hospital had ever observed any issues with the product prior. This device, as we all know, is extensively used in the neonate after delivery and for transport purposes.

The manufacturer’s instructions say that the device will warm to 40 degrees centigrade once the sliver disc is compressed. Unit manager recreated the scenario after the event and was able to obtain temperature ranges between 40.2 degrees centigrade and 40.6 degrees centigrade. This was taken with the temperature probe beneath the infant warmer gel pad and the mattress and also on top of the infant warmer mattress on the patient side near the radiant warmer head. It took about five minutes for the device to reach the range of the temperatures listed and the patient was apparently placed correctly in the infant warmer mattress….

A labeling review for the device found that the peak temperature of the pad is dependent on the starting temperature of the pad itself and not the environmental temperature.

We found this report interesting because often, these warmers and these pads are used with radiant warmers. So if this is indeed an accurate description of what took place and accurate information from the labeling, then we should be seeing this a lot. This type of report should be happening almost everyday and multiple times a day. Because the only report we’ve seen of such a burn on any patient, we’re trying to understand really the dynamics of what you see in the NICUs with regard to the use of these warmers, the mattresses in conjunction with the radiant warmers.

So if you’ve seen this experience or had a similar problem, we’d love it if you could chime in at this time.

Diana: Dr. Francis, my name is Diana. And while I’m interested also in what you were saying on the infant transport mattresses, a colleague and I were talking about another problem that we’ve seen with transporting isolettes. That’s particular with the battery pack failing on those devices. Has anyone else seen something of this nature? Have they worked with any manufacturers? Is there someone, perhaps, that we could speak with at the FDA on this matter?

Dr. J. Francis: Yes. I’m available to talk about this at any time and any of us, especially Suzanne. I have also reviewed some of those reports as well.

S. Rich: This is Suzanne. If you have anything, this is just as we’re waiting to see if people have comments on the infant warmer mattress, but if folks have any other questions or concerns that they’d like to share about this, the battery pack or any other issues they’d prefer to share via e-mail; we’ll be providing our e-mail addresses and contact information.

Moderator: We have a question from line number 404. Please go ahead.

Line 404: Hello. I can maybe help you out with your issue on your transport monitors. Recently, we’ve had some discussions in our shop and we had some transport units down from our ambulance team suggesting that the battery life on the units aren’t producing the life it’s supposed to during a transport.

What we found out is the unit - I’m not sure what unit you’re using, but we found out that the battery charging system is not normally the fault on that point. It’s where it’s looking for the battery to be discharged at a certain level. That needs to be recalibrated. It should be PM procedures that your clinical engineer or your biomed does on a normal PM procedure if that helps you out.

Dr. J. Francis: It sure does because this was brought up by another KidNet site, a problem that they’ve been having. They were saying it was a real pain in the you know what, especially with emergent and urgent situations. So that’s something that was not discussed.

I’m just double-checking my notes here to make sure that they did not have anything about that. I think their concern was that they purchased three of the same models over the past two or three years and all of these had issues with the battery packs not holding their charges. But I will get back to this hospital and ask if they have done the PM that you’re talking about.

Evidently, the company was very receptive to them. They had actually replaced these packs. But the PM is certainly something that it sounds like, to me, logic would dictate, that doing PM first might avoid the need for replacement. And even if we do PM and we’re still getting these types of problems, than it really does escalate the need for a report and we can work with the manufacturer. So I certainly appreciate that.
Does anybody else here around the table or elsewhere here at FDA have anything to say about that, the battery issue that our caller 404-- Oh, okay. I see a hand here in the room. In the back of the room here, we have about ten people sitting here as part of the call. This is Kathy Weil. She is one of our reviewers that actually reports on cardiovascular devices. I’m not even going to be able to tell you which ones, but she’ll be able to tell you. Thank you, Kathy.

K. Weil: I actually review batteries as well for all class devices. What I found when talking to some of the reporters, and you might want to comment on this. When I have called user facilities and asked them about their preventative maintenance with batteries, they say they have so many things with battery packs in them, that they have difficulty keeping up with the preventative maintenance on those batteries. And that’s why these issues happen to them as well.

So if any of you want to share how you have handled that situation because of the numerous batteries you have; if you have, say, a maintenance schedule or some easy way that you determine that that battery and that pack because the IVs have them, the monitors have them, the transport monitors have them. There are just such a … of devices that often I just get some pushback as to people saying, “Well, we can’t maintain everything and batteries is one of those things.”

So the gentleman who brought that topic up, you might have some input that you’d like to share with your colleagues, as well as to how you handle and address that issue.

Line 404: …A situation about that or a manufacturer, a person can contact me and I could walk through with that site if they would site and tell them what we do and how we solve the problem that we had in the past here about that.

But really, it’s not the charging system. It’s how they use the units and when they plug them in. Most of the battery situations that you have, just like anything; they have to be drained down and then recharged. What’s happening most of the time if it goes on an ambulance or it’s in transient, the time period is so short and then we recharge them again. It almost like resets itself for a shorter period of time.

So if you have any issues, please, if MedSun would get a hold of me, they could contact me directly and I would like to talk to you if that’s a problem.

T. Powell: Thank you so much. This is Tina Powell. If you could e-mail me at tpowell@s-3.com with your contact information, we’ll follow-up with you and we’ll have a piece in the device safety exchange and the MedSun newsletter on that topic. We did have an audio conference with Tim Decutiny of Health Canada some months ago on the topic of batteries and how to keep batteries ready for the situations you will encounter in healthcare, as well that we could perhaps pair up with this discussion and provide feedback to MedSun sites. So thank you so much. If you could just send me an e-mail to tpowell@s-3.com, then that will provide a good opportunity for follow-up with you. Thank you.

We probably want to go on to our next major issue, if that’s okay with you, Jackie and Suzanne.

Dr. J. Francis: That’s fine. Also just to make a note that this device safety exchange is actually very useful along these lines for future reference outside of this issue. So I would suggest that all of our KidNet participants keep an eye on that exchange on a regular basis.

T. Powell: We’ll have information in the follow-up material for you about that.

S. Rich: So our next topic is actually to discuss a question on possible medical devices safety issues that was submitted by a MedSun reporter. Are we ready to go?

Dr. J. Francis: It’s on an ICU monitor and we had gotten a phone call, actually. As you well know, the folks that have been reporting to us for a while, and you clinicians that are new, I just want to let you know that oftentimes, we get calls to our MedSun folks, our contractors, SSS, Social and Scientific Systems. A lot of times what they do is they get calls of concerns of, “Well, is this really something that should be reported,” or “This is a type of a problem we might be having,” “Have you seen this kind of thing before?” They work with the FDA specialist in order to be able to provide some background and help some of the reporters.

Typically, if it’s significant enough for folks to make a phone call, it’s significant enough for a report. So very rarely do we get these calls. But we did get one on an ICU monitor problem. We actually have a MedSun reporter that was willing or is willing to share what it is and tell you what the problem is and how their facility has developed a solution strategy to address the problem.

Moderator: Yes. We have a question now from the line of 404 again. Please go ahead.

Line 404: Hello. We currently switched over our ICU monitors from one brand to another vendor. During our setup phase or our first like month trial on the new equipment, we were having issues with zeroing invasive pressures. What we found out is, and we brought in the manufacturer of this device to show them what our problems were. Our kind of like a little bit of delay and frustration, most of it, was from the nursing staff that was trying to set the line.

So what happened is the monitor screen actually flashes to the question marks, to zero and then it says that it’s in transient to auto zero, the piece of equipment or cable. It blanks out, the screen blanks out and on the bottom of the screen, it gives you a message on the right side of it and it says, “Auto zeroing taking place.”

At that point, the nurse wasn’t really actually looking at the bottom right-hand corner of the screen. They were actually looking at the top corner of the screen and looking for it to auto zero. So when the screen blanked, they thought it was auto zeroed and they would start the process. What happened is that when the manufacturer was here, they were looking at it the same way. After review, there was just a slight delay between the screen blanking and where the message comes out. That seemed to be an issue and more frustration than anything while we’re trying to set the line.

T Powell: Can you tell us more about what happened as you were investigating and moving forward with this?

Line 404: I can tell you a little bit. I’m one of the nurses that works on the unit. When we first started having the problem, we noticed that we could zero from the detachable portion that fit into the transport monitor with more difficulty than a plug-in module. We had no idea why that was.

We had problems with being unable to get pressures because we couldn’t get the lines to zero. What we did is we called the company and we ended up using, instead of the detachable portion, we used more of the plug-in modules because that was all we could get to work. What we finally figured out is that these monitor differed from our previous monitors. On our previous monitor when it showed zero, it was zeroed and you were done. On these monitors, you have to watch for that little tiny message down in the left corner. So it was really an education piece and it’s actually still ongoing. Every now and then, I find a nurse who still can’t get a line to zero and I have to point it out to her. So I think from the perspective of the monitor and the nurse and getting it to work better, had that message been a little clearer, we probably wouldn’t have had the problem.

Line 404: Or flashing at that point. So you could actually be looking at that side of the monitor for the zeroing to be taking place.

Marilyn Flack: Have you been working directly with the manufacturer on this issue?

Line 404: Yes, we were.

M. Flack: It sounds like they’re responsive then. Are you happy with how things have worked out? Do you still have any outstanding concerns?

Line 404: From a nursing perspective, I think we’re pretty happy. We do love the monitors. I still do think that it would be a good thing if the manufacturer made that throw message larger and more easily readable.

Dr. J. Francis: Has the manufacturer offered to do that?

Line 404: Not at this time. That’s part of their setup plan, to have the messages on the bottom of the screen and not where the numerical numbers play. They’re actually on opposite corners of the display. So if there’s going to be a delay or it’s still zeroing, it should actually flash up where the numerals are being displayed.

T. Powell: Absolutely. So I was wondering if you could-- Are you still in conversation with the manufacturer? This is something we could contact them about, but they often tend to respond very quickly to their customers. I know that you said that you love the monitors, but if you get a new nurse in who just doesn’t know about that right away, then you could have a patient problem. So are you going to give a little pushback to the manufacturer?

Line 404: We’d love for you guys to get involved.

T. Powell: Okay. But again, if we refer back to you then-- I guess I want to make sure that you’re behind this.

Line 404: Absolutely. They are fully aware of what our needs are and our concerns at this time.

T. Powell: I don’t believe we had a report in the database on this. So if you could please enter it, then we could send that to the manufacturer. That’s really our way into the system. Then we could send them what we call an additional information letter. If you could take about five minutes and just throw that in tonight, that’s great.

Line 404: I put it in DSX because I was trying to find out if anybody else had anything, such as the problem we were having.

T. Powell: Right. Thank you so much for that. The DSX, though, does not turn into a MedSun report. They’re segmented in the database. Have you entered a report into the actual system, or does your risk manager do that?

Line 404: Both of us do.

T. Powell: Okay. Great. So if you could take some time to do that, then we will be happy to follow-up with the manufacturer on that.

M. Flack: If you’re concerned about the verbiage, when you do the report and you want to refer or list what you’ve put in the DSX and cut and paste into it, that’s fine. Trying to make it painless for you.

Line 404: Sounds great.

S. Rich: We really appreciate it. Does anybody else have anything to share about that, about this reported problem and/or similar problems? Dr. Francis is also saying this is the time we’re asking for any concerns that anyone might be having with medical devices and safety with their pediatric patients.

T. Powell: You do not need to indicate where you’re from or your name. We know that we have a number of sites on the call who have reported in the past and have interesting situations that they might want to discuss on this call.

S. Rich: Can I ask one question? This is Suzanne. I have a nursing background. As part of our efforts to be as responsive and as interactive as we can with the frontline users of medical devices, we periodically go in and visit folks, not for cause because we think there’s a problem with you or your devices. But sometimes we have an opportunity to visit with you folks and see first-hand some of the constraints and perspectives and challenges that you have in your day-to-day work.

Part of the reason we do that is we like chatting with folks to see what types of things make it a little bit more difficult for folks to spread the word about reporting medical device adverse events, related adverse events. Are there any other barriers to reporting any types of adverse events, because we’re able to share this information not only within our Center for Devices and Radiological Health, we can also take some of our lessons learned and work with some of our sister FDA Centers, such as FDA’s Center for Drugs and Center for Biologics on products they regulate.

I just wanted to know if anybody had anything that they would like to share about barriers to reporting, whether you be a biomedical engineer, a respiratory therapist, physician, or a nurse. Also, if you have any concerns about the barriers, what types of suggestions might you have that we could do to help you?

Moderator: We have a question from line number 353. Please go ahead.

Line 353: Hello. I was just wondering if you were going to add a feature where you could upload photos or pictures of devices that have failed. That was one idea.

S. Rich: Oh, that’s a great idea. That’s something that we can look at. Our MedSun project director, Marilyn Flack, is sitting in on this call and indicates we have a plan on this. So I’m going to put her a little bit on the spot and ask if she can give us just a little bit more details on how and when this might occur.

M. Flack: It’s possible right now in the DSX, the Device Safety Exchange software. So it’s simply a matter of transferring that coding over to the MedSun software. It’s on our “to-do” list. We’re trying to get a new version of software out to you hopefully over the next month and then after that, we can address that. But, yes, we would love to get more pictures in.

Line 353: Okay. Great.

S. Rich: Thanks.

S. Rich: Okay. Well, now we’re going to wrap up and talk about next steps and that’s going to be done by Tina.

T. Powell: Thank you. Well, we are going to ask that each of you from MedSun sites go back onto the registration site on Wednesday, two days from now. You can actually fill out the evaluation form today if you wanted to. And you’ll receive a certificate that indicates that you were part of the KidNet Roundtable, the first of its kind. But in two days, you will have available to you the information from this call, including some of the information that you yourself have provided on the call.

With the few minutes that are left, I just would like to hear from you about whether you would like certain types of continuing education credits to be involved in these roundtables if possible and if so, what type. Also, your other comments about the roundtable itself, this is our first one. We will be developing this and having what we think will be quarterly meetings. So the next one would be approximately January 15th where, again, we would visit some of the important reports that have been received through the MedSun project that pertain to pediatric patients from sites that are participating in the special KidNet part of MedSun.

But I’d like to hear from you if you have comments on the roundtable itself, the issue of continuing education credits and we’ll open this, Linda, at this time. Anyone would like to make a comment or a suggestion, please press star one now.

I would ask each of you who is on the call from a MedSun site to consider indicating your comments about the roundtable itself at this time.

T. Powell: If you could please press star one, we’d love to hear your comments or from anyone who is on the call right now. We are interested in your comments about the roundtable, about the issue of continuing education credits.

T. Powell: Well, I would just when we have the conversation in January; we really are going to ask for substantial input in order to make the roundtable concept workable. We are going to be making the information from the call available to you. Feel free to share it with others. If any of the people on the call today have not yet had someone trained to be a reporter from your NICU or PICU, then we will follow-up with you and see if you would like to arrange for a Webcast orientation.

It’s quick. It’s easy and then staff from your PICU and NICU will be able to report to MedSun either directly or through others who are already MedSun representatives, but they’ll be informed about the project and it’s purpose, as well as how to report.

Thank you so much for your participation on the call today. We think that we will be improving the way that the calls will work and we’ll be seeking input from you ahead of each call. We are definitely interested in your comments about the roundtable, about the issue of continuing education credits, if that’s going to be possible, for certain audiences.

We thank you, again, for your time and for your participation in the project.