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Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

Recalled March 20, 2024 · FDA recall Z-1283-2024 · Fresenius Kabi USA

Hazard
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. · FDA Class II
Units
6 US
Sold at
US Nationwide distribution to the states of CA, CO, NJ, WI, UT.

Description

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.

Product
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Manufacturer(s)
Fresenius Kabi USA, LLC

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →