Medical Device Recall: LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Fresenius Kabi USA, LLC · May 10, 2023
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.
States Affected
NATIONWIDE
Quantity Affected
6 US
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1283-2024
Status: completed
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.