Public Citizen Slams Baxter Infusion Pump RecallMar 13, 2009 | Parker Waichman LLP The advocacy group Public Citizen has criticized the Food & Drug Administration (FDA) for the way it has handled the most recent recall of Baxter International's COLLEAGUE Infusion Pumps. The Baxter infusion pumps - which have had numerous safety problems in the past - were only recalled this week, though the problems that sparked the recall were actually known in January.
The recalled Baxter COLLEAGUE Infusion Pumps are designed to monitor a variety of sensors, electronics and medical-control software during patient therapy, and to automatically shut down and sound an alarm in the event of an unexpected or potentially dangerous situation.
As we have reported previously, Baxter hasn’t sold COLLEAGUE infusion pumps in the U.S. since 2005 because of a number of defects, including battery failures, problems with false alarms and alarm failures, and inadequate infusion. While Baxter infusion pumps have been subject to seven recalls since 2005, and have been implicated in at least 19 deaths, they have never actually been pulled from the market. In fact, around 200,000 are still in use in hospitals and clinics throughout the U.S.
Earlier this week, the FDA announced the seventh Class I recall of COLLEAGUE infusion pumps. A Class I recall is the agency's most serious type, and is issued when a device poses a risk of serious injury or patient death if it malfunctions. In this case, the FDA issued the recall after Baxter had sent an Urgent Device Correction letter to its customers on January 23. Six serious injuries and 3 of the 19 deaths attributed to Baxter Infusion Pumps have been linked to the problems cited in the letter.
The letter warned customers about failure codes in COLLEAGUE pumps that could cause them to alarm and stop infusing while delivering critical medication and fluids to patients. The letter also included information warning of the possibility of the device overheating resulting in smoke and fire if improperly cleaned and/or if there is compromised battery harness insulation. Additionally, Baxter notified customers about a high occurrence of damaged battery messages related to the use of the pump as a battery-operated device.
In a letter to the FDA, Dr. Sidney Wolfe, Director of Public Citizen, questioned the timing of the latest Baxter infusion pump recall. "Why did it take the FDA until March 11th, nearly seven weeks, to decide that this problem was serious enough to merit being classified as a Class I recall," Dr. Wolfe wrote.
Dr. Wolfe also criticized the FDA for allowing the Baxter infusion pumps to remain on the market. "Why has the company thus far announced that hospitals should continue to use the devices and discontinue use only if a malfunction occurs?" he wrote. "Why has the FDA not used its authority for mandatory device recalls, to remove these devices which have a long history of serious, life-threatening problems?"