Recall Z-0950-2017 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris Pump Module, Model No. 8100 and AIL sensor kits, P/N 147083-102 and P/N 49000221. The Alaris Pump module is a large volume infusion pump offered under the Alaris System. The Alaris Pump module will deliver medication and fluids using IV administration sets for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous or epidural
| Date | Jan 18, 2017 (initiated Dec 2, 2016) |
| Status | Terminated |
| Reason | During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted. |
| Root cause | Component change control |
| Action | Carefusion (BD) sent a Medical Device Safety Notification letter dated December 2, 2016, to all affected customers. The letter informed customers that BD has identified an issue with the Alaris Pump module. The letter informs the customers that the firm has received reports of Air-In-Line (AIL) alarms that have occurred when no air is observed in the line. Customers were informed of the issue and of the potential risk involved. The letter informs the customers of the actions for users and additional actions for biomedical engineering. Customers with questions regarding recall related que |
| Quantity | 382,635 units |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K950419 | THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS Imed Corp., Jun 21, 1995 |