Baxter Ordered to Recall & Destroy Defective Medical Pumps

May 6, 2010
By Gabriel Mejia, Esq. on May 6, 2010 4:10 PM | | Comments (0)

Baxter International has been instructed to recall and destroy its Colleague line of hospital infusion pumps because of what has been described by the Food and Drug Administration (FDA) as "a long-standing failure" on the part of Baxter to correct numerous defects of the medical device. Although the FDA has for years tried to work with Baxter to correct the pump problems, the agency found Baxter's most recently submitted plan to address the defects was unacceptable because it exposed patients to potential injury for too long a time. The recall will affect about 200,000 pumps according to a Baxter spokesperson.

Infusion pumps are used to deliver timed and calibrated amounts of fluids and medication to hospital patients. However, the Baxter Colleague pumps, which have been labeled by the FDA as causing "persistent safety problems", have been the subject of previous recalls for defects such as battery problems, inadvertent shut-off, and other potentially dangerous or fatal errors.

The FDA has documented approximately 56,000 reports over a five year period of complications with infusion pumps in general including serious injury and more than 500 deaths. Although not all of these incidents are linked to the defective Baxter pumps, in 2005, the FDA confiscated 7000 Colleague pumps after receiving adverse incident reports of 16 patient injuries and seven deaths associated with the defective Baxter device. Hospira, a competing manufacturer and maker of the Symbiq infusion pump, also recently announced it was withholding shipment of its infusion pump amid customer complaints of defective alarming devices.

Defective infusion pumps are a safety risk because patients may be over-medicated, under-medicated, or not medicated at all. Many injuries to patients are directly related to infusion pumps with design or manufacturing defects attributable to the manufacturer of the device. An experienced personal injury attorney can help patients injured by defective infusion devices determine if they are entitled to compensation for their injuries.

Gabriel Mejia, Esq. is a Coral Springs personal injury attorney handling accident and injury cases in Florida for Law Offices Cytryn and Velazquez, P.A.

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