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US FDA classifies Fresenius Kabi recall of infusion pump as Class I

The U.S. Food and Drug Administration has classified Fresenius SE & Co. KGaA unit Fresenius Kabi AG's recall of an infusion pump system as a Class I recall — the most serious type of recall.

Fresenius Kabi initiated the recall of all lots of its Volumat MC Agilia Infusion System and Vigilant Drug Library on June 21.

The infusion pump is used by healthcare professionals to deliver certain fluids — including medications, blood and blood products — intravenously via an infusion tubing set into a patient's body. The system has a notification system based on different priorities of alarms to notify clinicians of specific pump conditions that require their attention. The Vigilant Agilia Drug Library is software for preventing dosage error. It can be used to configure drug limits and pump settings.

According to an Aug. 12 FDA notification, the priority of one of the alarms, which is triggered when the infusion is complete, is configured incorrectly as low priority. The alert in question results in the therapeutic rate of a medication changing to a nontherapeutic rate.

The regulatory agency noted that not responding to this type of alarm for a critical medication can cause a delay in care or underinfusion of medication that may lead to death or serious injury because the patient will be receiving a nontherapeutic rate of medication.

One death has been reported outside the U.S. where a healthcare provider did not adjust the infusion after changing the drug bag and then did not notice the alarm signifying the end of infusion. No other related instances have been reported in the rest of the world, including the U.S.

Fresenius Kabi will change this alarm from low priority to high priority to ensure that healthcare providers know that the infusion has been completed.

In addition, the company has identified four software errors occurring with both the Volumat MC Agilia Infusion System and Vigilant Drug Library that may cause overinfusion or underinfusion of fluids or medications. These software issues could cause serious patient harm or death. There have been zero injuries and 14 complaints reported related to these errors.