Company:Baxter Healthcare Corp.
Date of Enforcement Report 8/29/12
Class l:
PRODUCT
Product Name Product Codes Serial Numbers
Automix High Speed Compounder System 2M8077 All
Automix Plus High Speed Compounder System 2M8075 All
Automix 3+3 Compounder System 2M8286 and 2M8286K All
Automix 3+3 Compounder System with Accusource Monitoring System 2M8287 All
Range of Manufacturing and Distribution Dates: November 1982 through December 2007
Use: 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.
REASON
Baxter Healthcare Corporation (Baxter) has initiated a voluntary recall of its Automix Compounder (Automix) because of 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.
On July 13, 2012, Baxter Healthcare Corp. sent “Urgent Product Recall” letters to affected customers. On August 22, 2012, Baxter sent another “Urgent Product Recall”1 letter to affected customers to re-emphasize that the failure modes identified in the previous communication could lead to improperly mixed TPN solutions; remind customers that Baxter was performing a voluntary, controlled product withdrawal of the Automix compounding system from the United States market by June 1, 2013; and recommend that customers stop using the Automix compounding system and transition to an alternative device
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