Baxter Infusion Pumps: Fake Repair Records, Shoddy Design Endanger Patients, Spark RecallsJul 30, 2007 | Parker Waichman LLP
Once again, Baxter HealthCare Corporation has revealed problems with several models of its infusion pumps. In the span of a just few days, the Food & Drug Administration (FDA) ordered two separate recalls for the pumps; and in one instance, patients treated with these pumps may have been endangered because of fraud committed at the company’s Phoenix service center.
Electronic infusion pumps deliver life-sustaining medications and fluids to patients through intravenous, intra-arterial, or epidural routes of administration. On July 27, the FDA announced that in June, it had ordered a Class I recall of 534 COLLEAGUE and Flo-Gard infusion pumps that had been returned to the company for repair. In a press release, Baxter said that 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. Baxter did not say how this fraud was allowed to occur.
A Class I recall is the FDA’s most serious type of recall action, and is only ordered when a device poses a serious risk of injury or death to patients. In the case of the COLLEAGUE and Flo-Gard pumps, defects in the pumps could result in over or under infusion. The pumps could also fail to detect either occlusions or air in the intravenous line, and they run a risk of causing electrical shock. Other malfunctions could cause infusions of life-preserving fluids and medications to stop. The company advised customers to locate the affected pumps and take them out of service as soon as possible. The pumps should be sent back to Baxter for repeat inspections and servicing. Baxter said it would provide loaner pumps to customers that require them free of charge.
The announcement of this recall came just days after the FDA announced a Class I recall of more than 4500 Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps. Ironically, these pumps had been distributed to replace infusion pumps recalled by the company in 2005. These upgraded pumps were recalled because of a software glitch that caused the pumps to alarm, display an error code and stop infusion. Prior to the recall, Baxter had received reports of 16 serious injuries linked to the malfunctioning pumps in the US. The malfunctions occurred during user programming with all three channels infusing fluids at the same time. In all cases, the pump stopped the infusions in all three channels, which caused it to activate an audible and visual alarm.
In light of the poor performance of so many models of Baxter’s infusion pumps, questions are being raised about company’s quality control programs. That so many patients could have been endangered because of falsified repair records and shoddy design is inexcusable. What steps Baxter and the FDA will take to prevent such occurrences in the future still remains to be seen.