Recall Z-1383-2011
Baxter Healthcare Corp. · initiated January 27, 2011
Product
AUTOMIX High Speed Compounder System, product 2M8077; 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.
Codes / lots: Product codes 2M8077, all serial numbers
Reason for recall
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.
FDA-determined cause: Other
Action taken
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.
Details
- Recall number
- Z-1383-2011
- Initiated
- January 27, 2011
- Posted by FDA
- February 22, 2011
- Terminated
- February 16, 2012
- Product code
- LHI – Set, I.V. Fluid Transfer
- Quantity
- 270 units
- Distribution
- 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.
- Recalling firm
- Baxter Healthcare Corp., Round Lake, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1384-2011 | AUTOMIX Plus High Speed Compounder System, product 2M8075; automated nutrition…The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The… | 01/27/2011Terminated |
| Z-1385-2011 | AUTOMIX 3+3 Compounder System, product 2M8286 (115V) and 2M8286K (230V), automated…The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The… | 01/27/2011Terminated |
| Z-1386-2011 | AUTOMIX 3+3 Compounder with Accusource Monitoring System, product 2M8287; automated…The AUTOMIX compounder may not respond correctly to the key pressed by the operator using the keypad. The… | 01/27/2011Terminated |