In the Urgent Device Correction letter, Baxter notified customers about failure codes in COLLEAGUE pumps that may cause them to alarm and stop infusing while delivering critical medication and fluids to patients. The letter also includes 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. The letter reminds customers that safe and effective use of COLLEAGUE pumps is dependent on specific battery care practices as described in the operator's manual. There have been serious injuries and/or deaths associated with failures identified in this letter.
The complete Urgent Device Correction letter is available on the company's website at http://www.baxter.com.
Customers with questions regarding this notice may contact Baxter at 1-800-THE-PUMP (1-800-843-7867), between 7 a.m. and 5 p.m. CDT. Any adverse events relating to this product should be reported to Baxter.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at
Baxter International Inc. (NYSE:BAX), through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
Baxter International Inc.