Infusion Pump Recall

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Infusion Pump Recall

On July 19, 2005 the Food and Drug Administration ordered the recall of all Colleague models of the Baxter infusion pump because they can shut down while delivering crucial intravenous fluids and medication to patients. The Baxter infusion pump recall is the FDA’s response to a March 15, 2005 classified customer notification distributed by the medical company (Baxter Healthcare Corporation).

The Urgent Device Correction letter issued in March 2005 alerted customers of the deadly user interface and error code problems associated with the Baxter infusion pump that could lead to serious injury or death. By the time the Baxter infusion pump notice was issued, three people had already died and another six seriously injured as a result of this defective medical device. It is estimated that approximately 206,000 Baxter infusion pump Colleague models have been sold to hospitals, physicians, and other medical facilities in the United States alone.

Serious injury from the Baxter infusion pump can be the result of user interface problems. It is possible with the Colleague models for its operator to accidentally press the OFF button instead of the START button when attempting to start the infusion process. External communication port failures are also a serious potential risk of Baxter infusion pump complications that could do serious harm to patients. Baxter has stated that it will alter the design of the pump software and make the pump more fault-tolerant, thereby mitigating the risk of life threatening complications.

Serious problems with the Baxter infusion pump are also related to failure codes. These complications can occur while the pump is in use, thereby disrupting the delivery of important medical fluids. Baxter recommends that, should one of these failures occur, the Baxter infusion pump should be taken out of use and inspected. Any medical facility that uses the Baxter infusion pump should have a back up plan (infusion device) in the event of a complication with this product.

Though the FDA issued its strongest recall over the Baxter infusion pump, the company is not accepting the return of those products currently in use throughout the United States and the rest of the world. Baxter stated in a corrective action letter that it is taking aggressive steps to implement design changes that will address and solve these serious problems. Distribution of those Baxter infusion pumps already sold has been temporarily suspended until the company has remedied these life threatening risks.

If you or a loved one has received intravenous therapy through a Baxter infusion pump and been seriously injured, you have the right to seek compensation for your losses and suffering. To learn more about the Baxter infusion pump, please contact us to speak with a qualified and experienced attorney who can evaluate your case to determine your legal rights and options.

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