August 30, 2012 -- AUDIENCE: Risk Manager, Pharmacy
ISSUE: 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. Fluids, such as water, cleaning solutions, and nutrition source solutions, may enter into the keypad of the Automix control module and may cause the Automix to generate an incorrect device response to an Automix operator’s key press. The intermittent electrical failures may cause the motors on the Automix to pump nutrition solution when not programmed to do so, or may cause the Automix to stop compounding before it has finished appropriately mixing the Total Parenteral Nutrition (TPN) Solution. Causes for the intermittent electrical failures have not been determined.
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.
BACKGROUND: Baxter Healthcare Corp. Automix Compounder Systems are automated nutrition compounders that use weight-based (gravimetric) measuring, often controlled by software, to provide compounding of total parenteral nutrition (TPN) solutions to a patient.
RECOMMENDATION: Customers should discontinue using the Automix compounder and transition to an alternative option as soon as possible.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Recall Notice, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm317448.htm
