FDA Adds Safety Recommendations for Baxter Colleague Pumps
The FDA is recommending additional safety steps on top of those listed by Baxter Healthcare Corporation these past months, when using the Colleague Volumetric Infusion Pump:
- “If possible, do not use the COLLEAGUE pumps in situations where delaying or interrupting therapy in order to reprogram or replace a malfunctioning pump may be life threatening, such as with critically ill patients being maintained on inotropic infusions and patients in mobile transfer units.
- Have a contingency plan to mitigate any disruption of infusion therapy (e.g., have a back-up pump available). Your contingency plans should take into account both the patient’s condition and the reasons for the infusion.
- Monitor patients and check the pumps frequently.
- Report any problems as soon as possible to Baxter and FDA.
- If your facility relies primarily or entirely on COLLEAGUE Pumps, you may wish to consider evaluating other options for infusion therapy.”
This infusion pump is used to deliver intravenous fluids across hospitals, including in the ER, ICU, labor and delivery and pediatric units, as well as in ambulances. Bloomberg reports the company lost $150 million last year from suspending sales of that product range, and it will spend $20 million covering related customer warranties. According to Baxter it is the most common medical pump used in the US with 206,000 units sold, plus an extra 40,000 sold abroad. Baxter is working on the product’s design, hardware and battery management to make it safer. Technical questions are answered at 1-800-THE-PUMP.
The paper trail about this device (mostly pdf files):
- December 13, 2005 Urgent Device Correction classified as a Class I Recall
- July 20, 2005 Urgent Product Recall
- March 15, 2005 Urgent Device Correction
- February 25, 2005 Important Product Information
April 29, 2006 Related topics: Product Recalls, Quality, Safety, Errors