Baxter COLLEAGUE Infusion Pumps Again Prompt FDA to Issue Class I RecallJul 23, 2007 | Parker Waichman LLP
Baxter International, Inc. is recalling 4,500 COLLEAGUE Triple Channel Volumetric Infusion Pumps. The infusion pumps, which were replacements for some of the defective COLLEAGUE pumps Baxter had quit selling in 2005, have been recalled because of a software glitch that causes the pumps to alarm, display an error code and stop infusion. The recalled devices are used to deliver three intravenous fluids to a patient at one time. Baxter has called the software problem a “heavy usage scenario” that was not replicated during the company’s tests of the device.
Baxter has received reports of 16 serious injuries linked to the malfunctioning pumps in the US. The Food and Drug Administration (FDA) has identified the move as a Class I recall, the agency’s most serious type of recall action. The Class I recall means that use of the infusion pumps could lead to serious health problems or even death.
COLLEAGUE infusion pumps have been a problematic device for Baxter. In February 2005, Baxter recalled COLLEAGUE 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 FDA also deemed the 2005 action a Class I recall. 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.
The triple channel COLLEAGUE pumps involved in this latest recall were part of a remediation program initiated by Baxter to replace the pumps from the 2005 recall. Baxter distributed the newly-recalled infusion pumps in the US between May 14 and June 20. The recall also affects 66 pumps outside of the country. Baxter has indicated this recall will not affect its remediation efforts for single channel pumps involved in the 2005 action. However, the company said that it does not know how the new recall will affect remediation for the triple channel infusion pumps, which it had expected would take around 12 months.
Baxter said that all of its customers with these devices have been notified of the recall, and the defective pumps have been removed from use. The recall does not affect about 75,000 non-upgraded triple-channel COLLEAGUE pumps and 200,000 single-channel pumps now in use.
Baxter also announced that it has found a way to correct the problem with the recalled infusion pumps. The company says that it will implement the correction once it receives FDA approval to do so.