Fresenius Kabi USA is recalling the LVP software for the Ivenix Infusion System (IIS) because of a software defect that can trigger an incorrect 'Fail-Stop' alarm when an administration set is loaded while an upstream blockage is present. Only 3 units are affected by this specific issue, which occurred in software versions 5.0.1 and earlier. This error causes the pump to stop working unexpectedly, which can delay life-sustaining therapy and lead to serious patient harm. The issue was resolved in software version 5.2.1, which was installed in September 2022.
The software defect causes a non-recoverable pump failure when it detects a blockage during setup, leading to a complete interruption of medical infusions. This delay in therapy can result in no harm, minimal harm, or serious medical consequences depending on the medication being delivered and the patient's condition.
Software Correction
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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