ICU Medical faces Class I recall of infusion system replacement batteries

A recall of nearly 62,800 replacement batteries used in several of ICU Medical’s infusion pumps has received the FDA’s Class I rating—the agency’s most serious, denoting a higher risk of serious injuries or death linked to use of the affected devices.

Infusion pumps like ICU Medical’s Plum 360, Plum A+ and Plum A+3 large-volume models are used to deliver drugs, blood and other fluids to hospitalized patients. They can be programmed to deliver exact dosages of the fluids at specific rates, freeing up healthcare workers from having to constantly monitor and manage treatments.

According to an FDA notice published Monday, the recall stems from an issue with the replacement batteries used in the pumps; though the pumps are typically plugged into an outlet during use, they can switch to battery power if a patient is being transported or the machine is otherwise unable to stay connected to AC power.

In March, ICU Medical began a recall of thousands of the batteries that were distributed last year.

Though the exact cause is still under investigation, the devicemaker has discovered a manufacturing defect in some of the batteries that could lead them to run out of power more quickly than expected—potentially leading to unexpected infusion pump shutdowns that could interrupt the delivery of medications and other fluids.

Entries in the FDA’s recall database show that the issue spans a total of 62,799 replacement batteries distributed around the world, all of which were made by Hitachi Chemical subsidiary CSB Battery. Just over 1,900 of the recalled batteries were sold in the U.S., according to the FDA, with distribution dates between February and December of last year.

To date, per the FDA, ICU Medical has received 54 complaints linked to the use of replacement batteries in its Plum 360 infusion systems and another 465 complaints from users of its Plum A+ and A+3 pumps. The company hasn’t passed along any related reports of injuries or deaths, but the FDA said in the notice that it has “identified an adverse event that may be related to the recall issue.”

In an urgent medical device correction sent in March to all users and distributors of the affected batteries, ICU Medical suggested that healthcare facilities keep their infusion pumps plugged into AC power as often as possible. If they must unplug from an outlet, they should first make sure the battery is fully charged, keep a close eye on its power levels throughout its use and, when a pump is being used to provide critical care, have a backup infusion system at the ready.

The company is working on making corrected batteries available to users, but in the meantime, it gave hospitals’ biomedical engineers the go-ahead to swap in new CSB batteries for the recalled ones.