LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Published March 20, 2024 · Recall initiated: May 10, 2023
Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Other
Recall details
- Manufacturer
- Fresenius Kabi USA, LLC
- Distributor
- US Nationwide distribution to the states of CA, CO, NJ, WI, UT.
- Lot
- UDI-DI 00811505030122 Software versions 5.2.1/5.2.2
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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