FDA Orders Infusion Pumps Seized

U.S. Marshals seized some 1300 defective intravenous infusion pumps Friday at the request of the FDA to prevent the devices from being distributed. In response, the manufacturer announced that it had suspended production, sales, repairs, and installations of the pumps.

The Alaris SE infusion pump has a design defect called "key bounce" that can cause overinfusion of medication, according to the FDA. The problem occurs when numbers on the pump's keypad register twice when only pressed once, speeding up the infusion rate.

The company was first warned about the problem by the FDA in August 1998 but it failed to respond appropriately, according to an FDA announcement. Pumps already in use will not be seized (some 140,000 have already been distributed worldwide), but in an August 15 recall letter Alaris promised its customers a warning label for the devices and a permanent correction for the problem when it becomes available. It also issued recommendations for minimizing the key bounce problem.