LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- May 10, 2023
- Posted
- March 11, 2024
- Recall Number
- Z-1283-2024
- Quantity
- 6 US
- Firm Location
- North Andover, MA
Reason for Recall
Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
Distribution
US Nationwide distribution to the states of CA, CO, NJ, WI, UT.
Lot / Code Info
UDI-DI 00811505030122 Software versions 5.2.1/5.2.2
Root Cause
Software design
Action Taken
Both issues were resolved through an update of the software to Version 5.8.0, which was installed at customer sites between May and August 2023. The firm did not issue a customer letter at the time. According to the firm, this issue has been resolved in all fielded product.