Device product
Alaris Pump Module Model 8100 (formerly Medley Pump Module) Subsequent Product Code: FPA. The Pump module is intended for facilities that utilize infusion for the delivery of fluids, medications, blood, and blood products using continuous or intermittent delivery through clinically acceptable routes of administration; such as, intravenous (IV), intra-arterial (IA),subcutaneous, epidural, enteral, or irrigation of fluid spaces. The Pump module is indicated for use on adults, pediatrics, and neonates.
Z-2205-2012
Product summary
- Event
- Event 62642
- Status
- Terminated
- Classification
- Class I
- Quantity
- 43,862 units total (40,780 units in the US)
- Official record key
device-enforcement:Z-2205-2012
Official wording
Reason: The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly
Code information: Model 8100; Lot/Serial numbers-various
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Australia, European Union, and South Africa.
Derived failure modes
-
Unknown
The recall was initiated because Carefusion has identified a potential risk associated with the Alaris Pump module model 8100. The pump module door keypad overlay may separate from the keypad assembly