—#97471

Product

AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition compounders; Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield, IL 60015 The Automix Compounder Systems are electromechanical positive displacement fluid compounding devices used in the admixture of large volume parenteral nutrition formulations via gravimetric weighing.

FDA product code: LHI — Set, I.V. Fluid Transfer
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Product codes 2M8075, all serial numbers

Why it was recalled

The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The incorrect keypad response issue can occur both in manual data entry mode (STD Mode) and when entering order numbers to download from host software (MAN ID Mode). It is possible that an incorrect volume and/or an incorrect solution could be admixed into the final bag.

Root cause (FDA determination)

Other

Action the firm took

Baxter Healthcare Corp. sent Urgent Device Correction letters dated January 27, 2011, via first class mail to all affected customers. informing personnel that use Automix compounders to exercise care when entering data, and verify the accuracy of the keypad response. The accounts were requested to convey this information to all users of the Automix compounders, emphasizing the need to verify data accuracy each time the keypad is used. The accounts were also requested to complete the attached customer reply form listing the model and serial number of each of the Automix compounders at the facility and confirming their receipt of the letter, and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to their local Baxter representative, and technical questions were directed to Baxter's Global Technical Services at 1-800-626-2667. After determining the root cause of the incorrect keypad responses, Baxter issued a follow-up correction letter on 4/27/11 outlining the recommended work practices to reduce fluid penetration into the Automix compounder keypad/control module.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Worldwide Distribution - USA - Nationwide including Puerto Rico, and internationally to Brazil, Canada, Colombia, Costa Rica, Czech Republic, El Salvador, Egypt, Germany, Guatemala, Honduras, Luxembourg, Mexico, Panama, Saudi Arabia, Singapore, Switzerland, Taiwan, Trinidad, Turkey, United Arab Emirates and United Kingdom.

Timeline

Recall initiated: 2011-01-27
Posted by FDA: 2011-02-22
Terminated: 2012-02-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97471. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.