Recall Class: Class I
Date Recall Initiated: July 13, 2012
|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.
Baxter Healthcare Corporation
One Baxter Parkway
Deerfield, Illinois 60015
Reason for Recall: 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.
Public Contact: If you have any questions, call Center for One Baxter at 1-800-422-9837, Monday through Friday from 7:00 am to 4:30 pm CST.
FDA District: Chicago District Office
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" 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.
Baxter recommends that customers discontinue using the Automix compounder and transition to an alternative option as soon as possible because accidental large variations in dosing of critical solution components, such as Potassium Chloride and Calcium Chloride, could lead to patient injury or death. Customers are also being instructed to consider additional quality control measures, such as laboratory analysis of the finished units, to ensure proper concentrations of compounded products.
Baxter recommends that customers seek any of the following alternative options:
- CLINIMAX and CLINIMAX E Injections – Baxter’s premixed, commercially manufactured parenteral nutrition products;
- ExactaMix 1200 and ExactaMix 2400 – Baxa’s ExactaMix compounding system for multi-source ingredient compounding;
- Other acceptable TPN management systems sold by other manufacturers, such as B.Braun - PINNACLE;
- Repeater Pump – Baxa’s pharmacy pump for fluid transfer and filling applications including reconstitution, sterile filling, and pooling;
- Manual Compounding of TPN; and
- Refund Option – For customers that own Automix systems, Baxter will offer a refund based on the depreciated value of the device.
For those customers who need additional time to transition to an alternative option, Baxter recommends these customers closely evaluate the need to use the Automix compounder in higher risk patient populations, such as pediatric patients, elderly patients, or patients with renal impairment. The firm is also instructing these customers to contact Baxter’s Global Technical Service at 1-800-626-2667, Monday through Friday from 7:00 am to 4:30 pm CST, by September 12, 2012, to request a Certificate of Medical Necessity (CN). Only facilities that contact Baxter’s Global Technical Services and request the CN by September 12, 2012, will have the option to continue to receive ongoing support and service during the transition period. Customers that do not request a CN by September 12, 2012, will not receive ongoing support, service and/or dedicated disposables for their Automix compounder.
Customers that request a CN must return it to Baxter by October 12, 2012. If the CN is not received by this date, customers will not be eligible to receive ongoing support, service and/or dedicated disposables for their Automix compounder.
Finally, customers were reminded that Baxter will withdraw the Automix compounder from the market by June 1, 2013. Past this date there will be no support, service or dedicated disposables for the Automix Compounder.
Customers with any questions regarding the communication were directed to their local Baxter representative, and technical questions are directed to Baxter's Global Technical Services at 1-800-626-2667.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.