Baxter Infusion Pump Recall: What Will Colleague Pump Users Do Now?
Baxter Healthcare Colleague Infusion Pump Recall
Baxter Healthcare, the U.S. subsidiary of global medical device maker Baxter International which reported 2008 earnings of $2.2 billion, was given many chances to fix design flaw problems with its Colleague Volumetric Infusion Pumps, but never did. Now, the FDA has told the company that it must:
- Recall all of its Colleague Infusion Pumps of which there are thought to be 200,000 in circulation
- Destroy the pumps once returned
- Reimburse customers for the value of the recalled device
- Assist in finding a replacement for these customers at no cost
The FDA's permanent injunction against the company comes after it received 56,000 reports of adverse effects / serious injuries and over 500 deaths related to the defectively designed Colleague Pumps.
A history of ignoring FDA requests
Baxter has a history of ignoring the FDA's requests to address issues with its Colleague Pumps and those requests go all the way back to 1999. Here's a quick chronology:
- 1999 2006: The FDA and Baxter go back and forth on design defect issues, but never come to agreement.
- June 2006: The FDA obtains a consent decree of permanent injunction in 2006 in which Baxter stops manufacturing and distributing Colleague pumps until it corrects manufacturing deficiencies and brings the devices into FDA compliance. Baxter never fully complies.
- April 2010: The FDA issues a Class I recall in April 2010 and orders Baxter to address the issues right away. It proposes to do so but says that it won't begin until 2012 and won't fully complete its fixes until 2013.
- May 2010: The FDA acts on language contained in the 2006 decree to obtain a permanent injunction against Baxter and forces the company's hand to recall and destroy the devices, reimburse customers and assist them in finding another device.
What will users do now?
That's the question which thousands of users and patients want answered. According to Baxter, hospitals, clinics and in-home users of Baxters Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition. Until then, FDA & Drug Litigation attorneys say that users of the devices which have been called defectively designed, subject to mechanical and electrical failures and contain software defects and user interface problems may be able to file product liability lawsuits against Baxter to be compensated for their injuries.