Baxter Pumps Recalled

July 21 , 2005: The FDA announced the recall of 255,000 pumps manufactured by Baxter Healthcare Corporation. The device can shut down and fail to deliver the critical medication and fluids to patients.

What you should know:

According to the FDA press release, Baxter has received six reports of serious injury and three reports of death that occurred when the pump unexpectedly shut down. The FDA has determined this to be a Class I recall, the most serious type of recall, involving situations in which there is a reasonable probability that use of the affected product will cause serious injury or death.

The recall includes all models of Baxter Colleague Volumetric Infusion Pumps which are used to give controlled amounts of medications and other fluids to patients through a direct line to the bloodstream. Approximately 255,000 of the pumps are presently in use, including 206,000 distributed in the United States. The recall is effective worldwide.

Dr. Daniel Schultz, director of the FDA's Center for Devices and Radiological Health, said, "Given the widespread use of these pumps and the multiple failure modes, the FDA is quickly informing users of this important safety issue. We will continue to monitor the situation closely and inform the public immediately of any new developments."

According to an FDA spokesperson, the federal agency has received "hundreds" of complaints about the pumps. The New York Times reported that the pumps shut down for a variety reasons, including software and wiring problems, while the FDA said one basic problem was that the On/Off switches are so close to the Start key that some nurses may mistakenly turn off the pumps when they actually intended to begin administering medication.

What can I do?

If you have experienced any adverse effects from use of a Baxter Colleague Volumetric Infusion Pump, you should immediately consult your physician. You may also want to consider your potential legal claim. If you would like more information, click here to fill out a free case review form or contact attorney Ron Goldser directly, toll-free at 800.755.0098. Zimmerman Reed is experienced in handling defective medical device cases and we welcome any questions you may have.