FDA slaps Class I label on Fresenius Kabi USA infusion pump recall

The FDA has designated a recall of Fresenius Kabi USA infusion devices and software as Class I, the most serious type of recall.

In June, Fresenius Kabi USA voluntarily began the recall of its Volumat MC Agilia volumetric infusion pump to upgrade an alarm that signals when the infusion is complete, and of its Vigilant Drug’Lib (drug library) software to fix anomalies.

Fresenius Kabi will change its “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. One death was reported outside of the United States related to a norepinephrine infusion, in which a provider did not adjust the “Volume to be Infused” after changing the drug bag and then did not notice the pump’s “low-priority” “Keep Vein Open (KVO), End of Infusion” alarm, the FDA noted. No other injuries have been reported in the rest of the world or in the United States.

The recall is also designed to solve four software anomalies occurring with both the Volumat MC Agilia Infusion System and Vigilant drug library that may cause over-infusion or under-infusion of fluids/medications, which could lead to serious patient injury or death, according to the company. There have been zero injuries and 14 complaints reported related to these software errors, the FDA said.

The Volumat MC Agilia is a small, lightweight, portable infusion pump designed for use in multiple hospital care areas, according to the company’s website. Vigilant Drug’Lib Agilia is a dose-error-reduction software application used to build facility-specific drug libraries and pump configurations, linked within hospital care areas.

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