Fresenius Kabi is recalling nearly 10,000 Volumat Infusion Pumps, warning that machine alerts may result in serious and potentially life-threatening medication errors and side effects.
The FDA announced the Volumat MC Agilia Infusion System and Vigilant Drug Library recall on August 12, following at least 14 complaints involving software errors.
The Volumat MC Agilia Infusion System is used to deliver fluids, including medications, blood and blood products, into a patient’s body in controlled doses. The pump administers fluids intravenously via a tubing set. It is used for children and adults.
The pump includes a notification alert system, with various alarms to notify healthcare providers of conditions that require attention. An optional Vigilant Agilia Drug Library software may be used to identify dose errors and help reduce them. It is installed on a computer that communicates with the pump via USB cable, and can be used to configure drug doses and limits.
The recall was issued due to software problems that may cause the alarm to sound indicating “keep vein open, end of fusion” (KVO), even when the infusion is actually complete. This causes the medication dose to change to a non-therapeutic rate which is incorrect for the patient.
If a healthcare provider fails to respond to a KVO alarm, a delay in care or under-infusion of medication can take place. This can lead to a patient’s death or serious injury because the patient will receive a non-therapeutic rate of medication.
So far, at least one death has been reported outside the United States linked to the recalled infusion pumps. The death was related to a norepinephrine infusion, where a health care provider did not adjust the “volume to be infused” after charging the drug bag and then did not notice the pump’s “low priority” KVO alarm.
As a result of the recall, Fresenius Kabi will change the KVO alarm from a low priority to a high priority alarm to ensure the heath care provider knows the infusion has completed.
Additionally, Fresenius Kabi identified four software errors with the system and library that may cause over-infusion or under-infusion of fluids or medications. The errors could cause serious patient harm or death. No injuries were linked to the software problem, but 14 complaints were received.
The recall affects the Volume MC Agilia Z021135, software versions 1.7 and 1.9a, and the Vigilant Drug Library Z073476, software versions 1.0 and 1.1. All lot numbers, all manufacturing dates, and all distribution dates of the devices are affected by the recall.
The class I recall include more than 9,400 Volumat devices and nearly 100 Vigilant devices.
Fresenius Kabi sent a recall notice to affected customers and later issued an updated letter regarding the problem and clarifying the issues. The letter also included actions customers should make to prevent harm to patients.
The software for both devices will be upgraded in two phases in July 2019 and September 2019.
Customers can contact Fresenius Kabi regarding the recall at 800-333-6925. They can report adverse events to the FDA’s MedWatch Adverse Event Reporting Program.