Recall Z-0552-06 ยท MEA Pump, Infusion, Pca
Baxter Healthcare Corp.
AP II Pain Management System infusion pump, product codes 2L3105, 2L3105K, 2L3105R, 2L3105T and 2L3105W; Baxter Healthcare Corporation, Deerfield, IL 60015
| Date | Apr 26, 2006 (initiated Dec 21, 2005) |
| Status | Terminated |
| Reason | Delivery of unrequested PCA doses of medication due to damaged PCA cords, partial sticking of PCA button, and fluid ingress into the pump or PCA button. |
| Root cause | Other |
| Action | Baxter sent Urgent Device Correction letters dated 12/21/05 to the direct accounts on the same date via first class mail. The letters informed the accounts of the potential for unrequested PCA doses due to an electrical short in the PCA circuit simulating repeated pressing of the PCA button. The unrequested bolus doses will not exceed the programmed prescription limits. The letter listed three conditions identified that can produce an electrical short in the PCA circuit and simulate repeated pressing of the PCA button: * Damaged PCA cord or button, * Partial sticking of the PCA button, and * |
| Quantity | 10,000 pumps |
| Distribution | Nationwide including Puerto Rico, and internationally to Canada, Chile, China, Hong Kong, Korea, Kuwait, Malaysia, Taiwan and Saudi Arabia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K926385 | BARD APII PUMP C.R. Bard, Inc., Apr 18, 1994 |