Baxter Infusion Pump Recall: Pump Failure Could Result in Death

Baxter Colleague Infusion pumps, which are widely used at hospitals throughout the United States to deliver IV fluids and medicine, have been recalled by the FDA because the devices could delay or interrupt the infusion of fluids, potentially resulting in serious personal injury or death.

The Baxter infusion pump recall applies to about 275,000 of the Colleague Single and Triple Channel Volumetric pumps that were manufactured and sold from February 1997 through December 2008.

Software and battery usage failures could cause the pumps to stop infusing fluids or medications which may be necessary to keep someone alive. There have been serious injuries and deaths associated with the failure of these pumps according to a statement released by Baxter Healthcare Corp.

While Baxer originally called the action an “Urgent Device Correction” in January 2009, the FDA re-classified it as a Class I recall on March 11, 2009. Class I recalls are the most serious type of recall, used in situations where there is a reasonable probability that the use of a product will cause serious injury or death.

The electronic infusion pumps are used to deliver medications or other fluids in controlled amounts to patients through epidural, intra-arterial (IA), intravenous (IV), and other methods of administration.

The sophisticated devices monitor several sensors, medical-control software and electronics during therapy and automatically sound an alarm and shut down in a potentially harmful situation.

The infusion pump recall applies to all Colleague Volumetric Infusion Pump Mono 2M8151 and 2M8152, CX 2M8161 and 2M 8163 and CXE 2M9161 and 2M9163 model numbers.

The Baxter Colleague Infusion Pumps have not been sold in the United States since 2005, due to battery problems, electronic failures, software glitches and other defects. Although Baxter Healthcare Corp. has attempted to repair and upgrade the defective pumps, problems have continued to occur with the replacements.

Baxter still does not intend to pull the pumps back from hospitals and other customers, indicating that they intend to fix the infusion pump problems in the field.