FDA Classifies Recent Urgent Device Correction On Baxter's COLLEAGUE Infusion Pump As A Class I Recall

Main Category: Medical Devices / Diagnostics
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 13 Mar 2009 - 6:00 PDT

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Baxter International Inc. announced today that the U.S. Food and Drug Administration (FDA) has classified Baxter's January 23, 2009 Urgent Device Correction letter to customers regarding U.S. COLLEAGUE® Volumetric Infusion Pumps as a Class I recall. Baxter issued the letter based on findings from its ongoing quality control processes. This action has been classified by FDA as a Class I recall because of the risk of serious injury or patient death if affected devices malfunction. Affected model numbers include: All COLLEAGUE Volumetric Infusion Pump Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161 and 2M9163.

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 http://www.fda.gov/medwatch.

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.

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