Summary
The FDA issued a Class II for LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 by Fresenius Kabi USA, LLC. Reason: Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or co.
Details
Source
Device Recall
External ID
Z-1283-2024
Action Date
2024-03-20
Status
Completed
Category
device
Product Description
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Lot/Code Info: UDI-DI 00811505030122 Software versions 5.2.1/5.2.2
Quantity Affected: 6 US
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-05-10
Company
North Andover, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 148 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Fresenius Kabi USA, LLC has 46 FDA actions in our database, including 46 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Fresenius Kabi USA, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Fresenius Kabi USA, LLC have FDA actions?
Fresenius Kabi USA, LLC has 46 FDA actions in our database, including 46 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1283-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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