Baxter COLLEAGUE Infusion Pumps Malfunction Yet AgainOct 24, 2007 | Parker Waichman LLP
Baxter COLLEAGUE infusion pumps have been malfunctioning again under certain conditions, prompting new warnings from the company. According to a letter sent to its Canadian customers, Baxter has received reports of incidents where the COLLEAGUE triple channel infusion pumps stopped infusing. According to the “Urgent Device Correction” notice issued by Baxter, the company is working on a software solution to fix the problem with its COLLEAGUE triple channel infusion pumps.
The Baxter infusion pumps affected by the correction notice include Baxter COLLEAGUE triple channel Mono, CX and CXE Volumetric infusion pumps with product codes of 2M8153, 2M8163, 2M9163, DNM8153 and DNM9183. According to the correction notice, Baxter has received reports from 3 Canadian customers of at least six instances where defective COLLEAGUE infusion pumps stopped infusing. In each instance, the pump issued an audible and visual alarm and displayed the error code 16:310:867:0002 before it stopped. Baxter said that this malfunction of the COLLEAGUE infusion pumps occurred when the capacity of the buffer memory device was exceeded. While no injuries have been reported in relation to the defective Baxter COLLEAGUE infusion pumps, the company said that lab tests of the pumps showed that this malfunction had a high probability of occurring under certain circumstances.
While it works to correct the problem, Baxter has advised customers to utilize only two of the three channels on these defective COLLEAGUE infusion pumps, and to use a single channel device in place of the third channel. Customers should also have a back up single channel device on hand when therapy with the COLLEAGUE infusion pump includes all three channels infusing, and both the dose mode and flow check are enabled. Also, Baxter warned that the dose mode feature on the COLLEAGUE triple channel infusion pump should not be used if it has not been previously enabled.
COLLEAGUE infusion pumps have long been a problematic device for Baxter. In February 2005, Baxter recalled COLLEAGUE infusion pumps because they had a tendency to shut down unexpectedly, thus interrupting the flow of life-sustaining fluids and medications. Prior to the 2005 recall, Baxter had received reports of six injuries and three deaths linked to the malfunctioning infusion pumps. The US Food and Drug Administration (FDA) deemed the 2005 action a Class I recall because the pumps had the potential to cause serious injury and possibly death when used. During that recall, the FDA seized 7,000 of the devices from Baxter’s Illinois headquarters. In October 2005, the agency cleared a modified version of the COLLEAGUE pump for marketing.
Over the summer, Baxter issued yet another Class I recall for nearly 1,500 COLLEAGUE and Flo-Gard infusion pumps after routine quality control inspections revealed that the infusion pumps could have been returned to customers without ever having been repaired. During those inspections, Baxter found that repair, testing and inspection data sheets for the infusion pumps had been falsified. At that time, Baxter said that it had dismissed three employees implicated in the fraud.