Pharmacy Services

Automix Automated Nutrition Compounder

August 29, 2012

FDA and Baxter issued a Class I recall for Baxter Healthcare Corporation Automix Automated Nutrition Compounder Systems. The recall is in response to key press failures due fluid entry into device keypads and intermittent electrical failures due to unknown causes. The cause of fluid entry into the keypad system has not been determined.

The recall was initiated July 13, 2012, for all serial numbers of the following Automix products:

  • Automix High Speed Compounder System – Product Code: 2M8077
  • Automix Plus High Speed Compounder System – Product Code: 2M8075
  • Automix 3+3 Compounder System – Product Codes: 2M8286 and 2M8286K
  • Automix 3+3 Compounder System with Accusource Monitoring System – Product Code: 2M8287

The Automix Compounder Systems are automated devices that use weight-based measuring to mix total parenteral nutrition (TPN) solutions. Fluid entry from water and cleaning and nutrition solutions can enter the keypad spaces and cause an incorrect device response. Intermittent electrical failures can cause the Automix device to pump nutrition solution when it is not programmed to or stop compounding before mixing is complete. Key response failures and intermittent electrical failures can lead to incorrect volumes, solutions, and incompatibilities in TPN solutions. These errors can compromise the accuracy of critically important TPN components (eg, potassium chloride, calcium chloride) and can lead to serious injury and/or death when compounding in high risk populations (eg, pediatric, elderly, renal impairment patients).

Baxter is performing a voluntary withdrawal of Automix compounding devices from the United States market by June 1, 2013. Baxter recommends against using these products. Transition to other alternative compounding methods or devices as soon as possible.

A Certificate of Medical Necessity (CN) needs to be completed by September 12, 2012, to continue to receive ongoing Automix compounder service and support during this transition period. This certificate can be requested by contacting Baxter’s Global Technical Service at 1-800-626-2667. Additional questions can be answered by One Baxter at 1-800-422-9837. Report any adverse events from these products to FDA’s MedWatch Adverse Events Program.

Additional information is available at the following links:

Updated
August 30, 2012; University of Utah, Drug Information Service. Copyright 2012, Drug Information Service, University of Utah, Salt Lake City, UT.