Device product
Alaris Syringe Module Model 8110 with software version 9.15 The Alaris Syringe Pump module is part of the Alaris System. The syringe pump delivers fluids in a manner similar to current syringe pumps on the market. Up to four Alaris Syringe pump modules can be connected to the Alaris PC unit which is the central programming, monitoring and power supply component for the Alaris System. The syringe pump uses standard, single-use administration sets and syringes with luer-lock connectors.
Z-2879-2016
Product summary
- Event
- Event 74508
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,000 units
- Official record key
device-enforcement:Z-2879-2016
Official wording
Reason: A software anomaly with the Alaris Syringe module software version 9.15 may cause an infusion to unexpectedly stop when the Syringe module is transitioning from one rate to another.
Code information: Software version 9.15
Distribution pattern: Worldwide Distribution: US(nationwide) and countries of: Canada, Australia and United Arab Emirates.
Derived failure modes
-
Device software or design
software anomaly