Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I Recall - Risk of Fluid Entry into Device Keypads
MedSun: Newsletter #76, September 2012

FDA MedWatch Safety Alert

FDA notified healthcare professional of a Class I recall of Baxter Healthcare Automix Automated Nutrition Compounder Systems, due to incorrect key press responses, caused by fluid entry into device keypads and intermittent electrical failures. The incorrect key response failure and the intermittent electrical failures may lead to improperly mixed TPN solutions (e.g. incorrect volumes, incorrect solutions, and/or solution incompatibilities). For critical components of TPN, such as Potassium Chloride and Calcium Chloride, large variations in dosing in highly vulnerable patients could lead to serious injury and/or death. Customers should discontinue using the Automix compounder and transition to an alternative option as soon as possible.

Additional Information:

FDA MedWatch Safety Alert. Baxter Healthcare Corporation, Automix Automated Nutrition Compounder Systems: Class I Recall - Risk of Fluid Entry into Device Keypads. August 29, 2012.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm317448.htm


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