Product Liability

FDA Class 1 recall of infusion pumps; danger of serious injury, death

The U.S. Food and Drug Administration (FDA) issued a Class 1 recall of electronic infusion pumps designed to deliver controlled amounts of medications or fluids to patients through intravenous, intra-arterial, or epidural administration.

Class 1 recalls are the most serious type of recall issued by the agency and involve situations where there is a reasonable probability that the use of the product will cause serious injury or death.

The recall, issued to health care professionals, includes certain models of the Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corp. issued the recall after it identified software and battery usage failures that result in a delay in or interruption of fusion that may cause serious injury and/or death.

Recalled models identified in the recall of the Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps include Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161and 2M9163. They were manufactured and distributed from February 1997 through December 2008.

The recall notice follows a January 23 correction letter sent from Baxter Healthcare Corp. to all its customers about failures that could lead to interruption of therapy, damaged battery messages, smoke and fire hazards and serious injury and/or death. It advised institutions to have contingency plans to verify that back-up pumps are available, and provided new steps for addressing an interruption of therapy with any failure code, instructions for addressing damaged battery messages, and instructions for proper device cleaning.

Heath care professionals and consumers may report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch/report.htm.

Source:
FDA MedWatch