More Baxter Infusion Pumps Ordered Recalled by FDA Due to Falsified Repair RecordsJul 26, 2007 | Parker Waichman LLP
Yet another recall of Baxter Infusion Pumps has been issued by the Food and Drug Administration (FDA). This time, the recall covers 534 COLLEAGUE and Flo-Gard pumps that were returned to the company for repairs. It is possible that the repairs were never made. The FDA has classified this latest action a Class I recall.
In a press release, Baxter HealthCare Corporation said that infusion pumps, which are used to deliver intravenous fluids to patients, had been sent to its Phoenix, Arizona service center for repairs. During routine quality control inspections it was discovered that the pumps could have been returned to customers without ever having been repaired. During the inspection, Baxter found that repair, testing and inspection data sheets for the pumps had been falsified. The company said that it had dismissed three employees implicated in the fraud. The recall covers COLLEAGUE Volumetric Infusion pump 2M8151 and 2M8153; COLLEAGUE CX Volumetric Infusion pump 2M8161 and 2M8163; and Flo-Gard Volumetric Infusion pump 2M8063 and 2M8064. Baxter said that it has made all of its customers aware of the recall.
The FDA chose to give the recall a Class I categorization because the pumps pose a risk of serious injury. Baxter’s press release said that a defect in the pumps could result in over or under infusion. The pumps could also fail to detect air in the intravenous line or occlusions, and they run a risk of causing electrical shock. Other malfunctions could cause infusions of life-preserving fluids and medications to stop. Baxter said that so far, no injuries have been reported as a result of the defective pumps.
This is the second Class I recall that the FDA has issued for Baxter’s infusion pumps in less than a week. On July 20, the FDA upgraded the company’s recall of 4,500 COLLEAGUE Triple Channel Volumetric Infusion Pumps to Class I status. The infusion pumps had been recalled because of a software glitch that caused the pumps to alarm, display an error code and stop infusion.
Those pumps were replacements for COLLEAGUE pumps Baxter had recalled in February 2005 because they had a tendency to shut down. Prior to the 2005 recall, Baxter had received reports of six injuries and three deaths linked to the malfunctioning infusion pumps. As with all of the other recalls, the FDA also deemed the 2005 action a Class I recall.
Baxter is urging its customers with these recalled pumps to contact the company at 1-800-843-7867 to arrange to have their pumps re-serviced. Baxter is also offering to provide customers with loaner pumps while the recalled devices are repaired.