Recall Z-1373-05 ยท MEA Pump, Infusion, Pca
Baxter Healthcare Corp.
Baxter Healthcare Corporation, Medication Delivery Division, Syndeo PCA Syringe Pump, product codes 2L3113 and 2L3113R;
| Date | Aug 16, 2005 (initiated Jul 6, 2005) |
| Status | Terminated |
| Reason | During an infusion in the 'Basal + PCA' or 'PCA only' modes, the SYNDEO pump may generate false Service Code 919 or Service Code 920, which will cause the pump to stop the infusion. Also, while attempting to turn on the device by pressing the On/Off key, the pump may not power up properly. |
| Root cause | Device Design |
| Action | Baxter sent Important Product Information letters dated 7/6/05 to all Syndeo Pump customers, to the attention of the Director of Nursing, via first class mail. The letter informed the accounts of the scenarios they may experience regarding Service Codes 919 and 920, and the pump not being able to power up properly. Mitigation for Service Codes 919 and 920 is to turn the pump off, then turn it on again, and reprogram the infusion. If the codes occur again, the accounts were instructed to take the pump out of service and contact Baxter Medication Delivery Services at 1-800-843-7867. Any ques |
| Quantity | 4392 units |
| Distribution | Nationwide and Canada |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031566 | SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 Baxter Healthcare Corp, Aug 19, 2003 |