Device product
NxStage System One S Cycler -High Permeability Hemodialysis System Model no. NX1000-4
Z-0337-2016
Product summary
- Event
- Event 72554
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-0337-2016
Official wording
Reason: Ultrafiltration Volume (UFV) may not decrease during treatment-software error. The UF pump may continue to run and remove fluid even after the target UF volume has been removed
Code information: Software version 4.9 and 4.10
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Device software or design
software error