Defective Baxter Colleague Infusion Pumps and the FDA

The problems associated with these Baxter Colleague Infusion Pumps date back to 1999.  Since then, there have been three different Class I recalls initiated including the one announced today.  These recalls have been prompted by the tendency for these pumps to shut down while delivering the nutrients and medications that patients needed, and different reasons for these unexpected shutdowns include:

• Electrical problems
• Battery problems
• Software problems
• User interface problems
• The tendency to overheat and lead to smoke and fire

Overall, these problems have generated approximately 56,000 adverse effect reports and more than 500 deaths.

In addition to the problems covered above, Baxter and the FDA have engaged in a negotiation to repair these units in order to avoid the ordered recall.  As of now, approximately 200,000 units remain in circulation despite the fact that none have been brought to market since 2005.  Ultimately, Baxter offered to begin the necessary repairs in 2012 and to complete them in 2013.  The FDA rejected this proposal and ordered the recall in response, basically ending the negotiations.

Contact a Defective Medical Devices Lawyer

Unfortunately, none of this legal wrangling helps the thousands of people who have suffered greatly because of these defective Baxter Colleague Infusion pump units.  If you or someone you love has been harmed by these products, contact the defective medical device lawyers at Atkins & Markoff today to schedule a free initial consultation.