Device product
Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
Z-1964-2025
Product summary
- Event
- Event 96822
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8027 units
- Official record key
device-enforcement:Z-1964-2025
Official wording
Reason: Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.
Code information: UDI/DI 05413765852428, All Serial Numbers
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Device software or design
design issue