Fresnius Kabi USA has recalled thousands of infusion pumps to address software issues that could result in serious patient harm.
This latest infusion pump recall involves the following products:
The Volumet MC Agilia Infusion System is a small, lightweight, portable infusion pump that delivers controlled amounts medications, blood, blood products, and other fluids to adult, pediatric, and neonate patients. The Volumet 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 can be used to configure drug limits and pump settings according to clinical practice.
Fresnius Kabi initially announced the Volumat infusion pump recall in June, when the company indicated it would be changing the “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. According to Fresnius Kabi, at least one death occurred outside the United States when a provider did not adjust the “Volume to be Infused” after changing the drug bag and then failed to notice the pump’s “low-priority” “Keep Vein Open (KVO), End of Infusion” alarm.
The Infusion pump recall will also correct four software anomalies affecting both the Volumat MC Agilia Infusion System and Vigilant Drug Library that may cause over-infusion or under-infusion of fluids/medications. Fresnius Kabi has received 14 complaints regarding this problem, but so far, none have involved patient injuries.
The U.S. Food & Drug Administration (FDA) recently declared this action a Class I recall, which indicates that use of the Volumat MC Agilia and Vigilant Drug Library could result in serious patient injury or death. Fresnius Kabi has issued a “Dear Health Care Provider Letter” detailing specific actions users should take to prevent patient harm until the company is able to make the software corrections.
Unfortunately, Fresnius Kabi wasn’t the only medical device manufacturer to announce an infusion pump recall this summer.
In July, Becton Dickson recalled thousands Alaris Pump Modules, Model 8100, and Alaris Pump Model 8100 Infusion Sets because of defects that have been implicated in at least 12 patient injuries. The FDA also declared the Alaris Infusion Pump recall a Class I recall.