LVP software of the Ivenix Infusion System recall: Software Issue
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Why was LVP software of the Ivenix Infusion System recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI 00811505030122 Software versions 5.2.1/5.2.2
- Product
- LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 6 US
- Distribution
- US Nationwide distribution to the states of CA, CO, NJ, WI, UT.
- Recall date
- March 20, 2024
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)