FDA-Device2024-03-20Class II

LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

Fresenius Kabi USA, LLC

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.

Sold states

US Nationwide distribution to the states of CA, CO, NJ, WI, UT.

Affected count

6 US

Manufactured in

50 High St Ste 50, N/A, North Andover, MA, United States

Products

LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1283-2024

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