Recall Z-1567-2014 ยท FRN Pump, Infusion
CareFusion 303, Inc.
Alaris Pump model 8100 with software version 9.1.18 and software upgrade kits with "Delay Until" Option and "Multidose" Feature 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 s
| Date | May 14, 2014 (initiated Apr 23, 2014) |
| Status | Terminated |
| Reason | CareFusion is recalling the Alaris Pump model 8100 version 9.1.18 because it may have a software issue that results in situation where the pump module will not properly delay an infusion when the "Delay Until" option or "Multidose" feature is used. |
| Root cause | Software design |
| Action | CareFusion sent an Urgent Medical Device Recall Notification letter dated April 23, 2014, to all affected customers. The letter informed the customers of the problems identified and the actions to be taken. Customers were informed that if the infusion starts earlier or later than intended and is not immediately detected and stopped by the clinician this could result in serious injury or death. Customers are informed although no adverse events or deaths have been reported there is a potential for this risk. If customers experience the issue while using the Alaris Pump module then they are |
| Quantity | 57,219 units total (55,756 units in US) |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Canada, AE, AU, and KW. |
| 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 |