Device product
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Z-3153-2024
Product summary
- Event
- Event 95240
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 17 units
- Official record key
device-enforcement:Z-3153-2024
Official wording
Reason: The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
Code information: UDI-DI: 00811505030122; Software Version 5.9.1 and prior
Distribution pattern: US Nationwide.
Derived failure modes
-
Device software or design
software has anomalies