Baxter recalls more infusion pumps

By Katrina Megget

- Last updated on GMT

Related tags: Fda

Baxter Healthcare remains in murky waters in regard to its infusion
pumps after announcing yesterday it would be recalling an
additional 986 of its Colleague brand pumps.

In July, the US company discovered falsified service documentation data on it Colleague and Flo-Gard pumps, which had been sent to be serviced or repaired but were returned possibly without having a service. Following the find, Baxter announced a voluntary recall on 534 infusion pump devices, which the US Food and Drug Administration (FDA) then classified as a Class I recall, the most serious class, because of the risk of serious injury or patient death. The additional recall relates to falsified electrical safety data involving the three Phoenix, Arizona, service centre employees who were dismissed from the company earlier this year for their alleged part in falsifying safety reports. The blow for Baxter comes at a time when the company was just starting to recover from the 2005 FDA Class I recalls and seizures of pumps for design flaws following at least six reports of serious injury and three patient deaths. In February this year, the FDA had given the company the all clear for a modified version of the Colleague volumetric infusion pump, which was a positive move for the company, who in 2006 was forced to sign a consent decree with the FDA agreeing to correct manufacturing deficiencies as well as ceasing manufacturing and distribution of the pumps. The Colleague device was one of the most commonly used volumetric pumps worldwide, generating $170m in worldwide sales in 2004. The company said the recent recall showed no links to injuries or deaths. "Baxter's investigation of the matter is continuing . . . This recall action impacts only pumps distributed in the US,"​ the company said in a statement. More than 250,000 Colleague brands pumps are used worldwide. A defect may result in over-infusion, under-infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in the line, and malfunctions where the pump will stop infusing and result in an interruption of therapy. The infusion pumps are medical devices that deliver intravenous fluids and medicine to patients.

Related topics: Upstream Processing

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