Device product
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Z-2635-2023
Product summary
- Event
- Event 92973
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1344 pumps
- Official record key
device-enforcement:Z-2635-2023
Official wording
Reason: Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set
Code information: (UDI): 00811505030122 Software Version: 5.0.0 and 5.0.1
Distribution pattern: US Nationwide distribution in the states of NJ, WI.
Derived failure modes
-
Unknown
Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set