Device product
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
Z-0950-2017
Product summary
- Event
- Event 75466
- Status
- Terminated
- Classification
- Class I
- Quantity
- 382,635 units
- Official record key
device-enforcement:Z-0950-2017
Official wording
Reason: During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.
Code information: All products manufactured or serviced in the time period October 2011 through June 2015.
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
During an infusion, a false Air-in-Line (AIL) alarm would cause the infusion to be interrupted.