U.S. Food and Drug Administration08.13.19
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.
Recalled Product
The Volumat MC Agilia Infusion System is an infusion pump used by healthcare 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.
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 healthcare 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 healthcare provider knows the infusion has completed. There has been one death reported outside of the United States related to a norepinephrine infusion where a healthcare 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.
Who May Be Affected
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.
Recalled Product
- Volumat MC Agilia Infusion System and Vigilant Drug Library
- Models: 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 healthcare 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.
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 healthcare 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 healthcare provider knows the infusion has completed. There has been one death reported outside of the United States related to a norepinephrine infusion where a healthcare 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.
Who May Be Affected
- Healthcare 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
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.
