Device product
Alaris PC unit model 8015 with software version 9.12 Product Usage: The Alaris PC unit is the central programming, monitoring and power supply component for the Alaris System
Z-1112-2013
Product summary
- Event
- Event 64653
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,090 total units
- Official record key
device-enforcement:Z-1112-2013
Official wording
Reason: The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s
Code information: not available
Distribution pattern: Worldwide Distribution USA Nationwide and the countries of Australia and Canada.
Derived failure modes
-
Unknown
The recall was initiated because Carefusion has identified potential risk associated with bolus programming with the Alaris PC unit (model 8015) software version 9.12. Automating infusion pump parameter input from either the electronic medical record (EMR) or the Alaris Auto-ID module for a continuous infusion with a bolus dose option may result in a loss of information from the Guardrails Data s