The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
- Product Name: Medfusion Syringe Infusion Pumps
- Models, Product Codes, and Software Versions: See Recall Database Entries
- Devices Recalled in the U.S.: 118,055
- Dates distributed: October 2004 to February 17, 2022
- Date Initiated by Firm: April 19, 2022
Smiths Medical Medfusion 4000 and 3500 Syringe Infusion Pumps are used to give fluids to patients in precisely controlled amounts. They deliver blood or blood products, lipids, drugs, antibiotics, enteral feedings and other therapeutic fluids through infusion tubing into a patient’s vein or through other cleared routes of administration. Syringe pumps are primarily used in the neonatal and pediatric populations or in operating rooms and intensive care units for the adult population.
Reason for Recall
Smiths Medical is recalling Medfusion 3500 and 4000 Syringe Infusion Pumps for eight software malfunctions that affect different serial numbers and software versions. These malfunctions may cause serious harm or death to patients from under- or over-infusion, or delays in the delivery of critical medications to patients.
The eight software issues are as follows:
(1) False alarm for Primary Audible Alarm (PAA) system failure
(2) Unanticipated Depleted Battery Alarms
(3) Abnormal circuit board behavior, which may cause internal clock system failure
(4) Intermittent Volume Over Time (IVOT) delivery mode where the infusion continues
after system failure
(5) Unanticipated clearance of Program Volume Delivered (PVD)
(6) False alarm for Rate Below Recommended Minimum for Syringe Size
(7) Incorrect bolus or loading dose time display
(8) Network configuration may affect pump communications.
Smiths Medical states there have been a total of 7 serious injuries and one death reported related to these issues. The Customer Notification identifies the injuries and/or deaths associated with each software issue.
Who May Be Affected
- Patients who are treated using the Medfusion 3500 or 4000 Syringe Infusion Pump.
- Health care personnel who use Medfusion 3500 or 4000 Syringe Infusion Pumps to deliver medications to patients.
What to Do
Smiths Medical sent an Urgent Medical Device Correction letter to customers on April 19, 2022. The letter included an overview of each issue, the affected pump models, the potential risk to patients, and recommended actions for clinicians and for biomedical engineers for several issues. Smiths provided the following additional instructions to customers:
- Locate all affected pumps in your possession and ensure all users or potential users of these devices are immediately made aware of this notification and proposed mitigations.
- As indicated in the Operator’s Manual, if the Medfusion pump is used to deliver life-sustaining medications, ensure an additional pump is available for situations where an interruption in infusion could be dangerous. If the Actions for Users for each issue aren’t adequate to resume the infusion, use a different pump to continue the infusion.
- Complete and return the response form to email@example.com within 10 days of receipt to acknowledge your understanding of this notification.
- Distributors: If you have distributed potentially affected products to your customers, please immediately forward this notice to them. Request that they complete the response form and return it to firstname.lastname@example.org
- Smiths Medical intends to address the issues described in this notice through upcoming software releases and will update affected pumps that are within their Service Life at no charge. Smiths Medical will contact you to schedule the implementation of the software updates when the updates are released.
Customers can contact Smiths Medical with questions or concerns.
- To report adverse events or product complaints:
Global Complaint Management, email@example.com
- Additional information or technical assistance:
Technical Assistance 1-(800)-258-5361
- Medical Device Recall Database Entries
- Customer Notification
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.