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.
- Volumat MC Agilia Infusion System and Vigilant Drug Library
- Volumat MC Agilia Z021135, Software Versions 1.7 and 1.9a
- Vigilant Drug Library Z073476, Software Versions 1.0 and 1.1
- Lot Numbers: All
- Manufacturing Dates: All
- Distribution Dates: All
- Devices Recalled in the U.S.:
- Volumat MC Agilia - 9,461
- Vigilant Drug Library - 83
- Date Initiated by Firm: June 21, 2019
The Volumat MC Agilia Infusion System is an infusion pump used by health care professionals that delivers fluids including medications, blood, and blood products, into a patient's body in controlled amounts. The pump administers fluids intravenously via an infusion tubing set and is intended for adults, pediatrics, and neonates. The infusion pump has a notification system based on different priorities of alarms (high, medium, and low) to notify clinicians of specific pump conditions that require their attention.
The optional Vigilant Agilia Drug Library is dose error reduction software (DERS) that is installed on a PC platform that communicates with the pump via a USB cable. It can be used to configure drug limits and pump settings according to clinical practice.
Image of Volumat MC Agilia with Vigilant Drug Library Installed
Reason for Recall
When enabled, the "Keep Vein Open (KVO), End of Infusion" alarm triggers when the infusion is complete. This results in the therapeutic rate of a medication changing to a non-therapeutic rate, as defined by the KVO rate. KVO alarms should be high priority. If a health care provider fails to respond to a "KVO, End of Infusion" alarm for a critical medication, a delay in care and/or under-infusion of medication can take place, which may lead to death or serious injury because the patient will be receiving a non-therapeutic rate of medication.
Fresenius Kabi will change their "Keep Vein Open (KVO), End of Infusion" alarm from a "low priority" to a "high priority" alarm to ensure the health care provider knows the infusion has completed. There has been one death reported outside of the United States related to a norepinephrine infusion where a health care provider did not adjust the "Volume to be Infused" after changing the drug bag and then did not notice the pump's "low priority" "KVO, End of Infusion" alarm. No other injuries have been reported in the rest of the world or in the United States.
Fresenius has also identified four software errors occurring with both the Volumat MC Agilia Infusion System and Vigilant Drug Library that may cause over-infusion or under-infusion of fluids/medications. These software errors could cause serious patient harm or death. There have been zero injuries and 14 complaints reported related to these software errors.
|Issue/Error||Description of the Problem||Device Affected|
|"Keep Vein Open (KVO), End of Infusion" alarm is "low priority"||When enabled, the "low priority" setting of this alarm may prevent the user from recognizing that an infusion is complete. In KVO mode, the pump transitions to a user-defined rate, which is not a therapeutic rate.||Volumat MC Agilia|
|Error 18||This error may occur when variations in the main external AC power are detected. When this happens, a "high priority" alarm occurs which stops the infusion.||Volumat MC Agilia|
|Unexpected Hard Limit for Programmed Bolus Under Specific Conditions||For a programmed bolus, if the "Volume Upper Hard Limit" was left blank in the drug library, and the clinician attempts to change the default "Volume to Be Infused" (VTBI) on the pump, the software will unexpectedly impose a volume hard limit, which may lead to over- or under-infusion of fluids/medications.||Volumat MC Agilia|
|"Waiting Start" Alarm Does Not Function Under Specific Conditions||Under specific circumstances, the "Waiting Start" alarm will not function. If the alarm does not function, the health care provider may not realize infusion has not started.||Volumat MC Agilia|
|Incorrect VTBI Calculations for Programmed Bolus Under Specific Conditions||Under specific circumstances, the "Volume to be Infused (VTBI)" may be calculated incorrectly leading to over- or under-infusion of fluids/medications. This occurs when the flow rate is less than or equal to 9.9mL per hour and the "ratio" between the numbers of the bolus dose and the bolus flow rate is exactly 1000.||Vigilant Drug Library|
Who May be Affected
- Health care providers and facilities using a Volumat MC Agilia Infusion System with or without the Vigilant Drug Library
- Patients receiving infusions with the Volumat MC Agilia Infusion System with or without the Vigilant Drug Library
What to Do
Fresenius Kabi sent an "Urgent Device Recall" letter to all affected customers on June 21, 2019. They issued an updated letter on July 26, 2019 to clarify that for the "Incorrect VTBI Calculations for Programmed Bolus Under Specific Conditions" software issue, flow rates equal to 9.9ml per hour (not only flow rates less than 9.9m per hour) are also affected. The letters included specific actions that users of these devices should take to prevent patient harm until Fresenius Kabi can make corrections on site.
As the company works to make corrections, the software for both devices will be upgraded in two phases: July 2019 and September 2019. Customers will be contacted by a company representative to schedule appointments to make the necessary software updates.
Customers with questions about this recall may contact Fresenius Kabi at 1-800-333-6925, press 3.
Fresenius Kabi planned to contact all customers within three days after issuing the "Urgent Device Recall" letter on June 21, 2019. If you have not been contacted, contact Fresenius using the contact information above.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experience using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX to 1-800-FDA-0178. Health care professionals employed by facilities that are subject to FDA's user facility reporting requirements