Fresenius Kabi USA is voluntarily recalling the Volumat MC Agilia volumetric infusion pump and Vigilant Drug’Lib software to fix software anomalies and to upgrade an alarm signaling when the infusion is complete.
The recall is designed to solve four software anomalies that could cause over- or under-infusion of fluids or medications, which in rare circumstances, could lead to serious patient injury or death, according to the company. The FDA is aware of the recall, but had not classified it in terms of potential harm to patients.
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.
As part of the recall, Fresenius Kabi will upgrade the pumps’ “Keep Vein Open (KVO), End of Infusion” alarm to a high-priority alarm from a low-priority alarm. The company said it has determined that a high-priority alarm is better suited to inform clinicians that the infusion volume is complete. If infusion must continue, the alarm can help prevent serious injury or death.
There have been no injuries or deaths reported in the U.S. related to this alarm, according to Lake Zurich, Ill.-based Fresenius Kabi. One death was reported outside of the U.S., related to a norepinephrine infusion when a clinician did not adjust the infusion volume after changing the drug bag infusion and also did not notice the pump’s alarms. No other injuries have been reported related to the “Keep Vein Open (KVO), End of Infusion” alarm.
If enabled, this alarm informs users that the infusion has transitioned to a user-defined “Keep Vein Open (KVO)” rate, which is not intended to be a therapeutic rate.The company said it has not received any reports of adverse events related to the software anomalies, but that it had received 14 related complaints.
Fresenius Kabi said it will upgrade the software and alarm at customer locations or at the company’s service center. The company is notifying its customers by letter with directions to immediately implement corrective measures to help prevent patient harm and will schedule training with each customer on these instructions. Customers will be contacted by a Fresenius Kabi USA representative or distributor to schedule a service appointment for the upgrades and also to schedule training on the supplemental user instructions.
The affected units are the Volumat MC Agilia volumetric infusion pump with software versions 1.7 and 1.9a (product code: Z021135) and the Vigilant Drug’Lib versions 1.0 and 1.1 (product code: Z073476).