Class 1 Recall of 774,000 Alaris Infusion Pumps

FDA has classified as Class 1 a Becton Dickinson/CareFusion recall of 774,000 Alaris System infusion pumps and modules due to software and system errors. According to a recall notice, the devices have experienced low battery alarm failures, “Keep vein open/End of Infusion” alarm priority errors, custom concentration programming errors, and various software/system errors.

The infusion pumps deliver fluids, medications, blood and blood products in controlled amounts. The recall notice says that the errors can lead to delay in infusion, interruption of infusion, slower than expected delivery of medication (under-infusion), and faster than expected delivery of medication (over-infusion). Serious adverse health events have been reported, including 55 reported injuries and one death, it says.

Last month, the company sent letters to customers telling them that they will be contacted to schedule a software update when it becomes available.