Faulty Medication-Infusion Pumps Recalled After Deaths
July 2005
The Food and Drug Administration (FDA) wants to know—did Baxter International Inc. fully inform the public after malfunctions of their medication-infusion pumps were linked to three deaths?
The FDA classified the voluntary recall of Baxter infusion pumps as a Class I recall, meaning there is a reasonable probability that use of the product will cause serious injury of death.
The medication-infusion pumps are used to administer medication intravenously. In addition to the three deaths, six serious injuries have been potentially linked to shutdown problems. World-wide, there are about 255,000 of the devices in use. The company said it would stop shipping the product immediately.
Baxter previously sent two notices, one on March 15, 2005 and one on July 20, 2005, about problems with the medication-infusion pump. The deaths and serious injuries were not disclosed in earlier warnings.
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Source: “Baxter Infusion Pumps Are Target of FDA Probe.” By Anna Wilde Mathews and Thomas M. Burton. The Wall Street Journal. July 22, 2005.
