Infusion Pump Software Defect Causes Incorrect Alarm and Therapy Delay
Fresenius Kabi is recalling software versions 5.0.1 and earlier of the Ivenix Infusion System due to a software defect that may cause an incorrect pump alarm, potentially delaying therapy. The defect was resolved in software version 5.2.1, released in September 2022.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The defect was corrected in September 2022, and this is a retroactive transparency notice. The potential harm is theoretical, ranging from no harm to serious harm depending on clinical context.
Plain-English summary
Fresenius Kabi USA, LLC is recalling software versions 5.0.1 and earlier of the Ivenix Infusion System (IIS, model LVP-SW-0004). A software defect identified in 2022 may cause an incorrect Fail-Stop Alarm when an administration set is loaded with an upstream occlusion.
When the defect occurs, the pump displays a non-recoverable Pump Problem alarm instead of resolving the condition. This malfunction may lead to delay of therapy administration. Patients may experience effects ranging from no harm to minimal effects to serious harm, depending on clinical circumstances.
Fresenius Kabi released corrective software version 5.2.1 in September 2022, which resolved the issue in all fielded systems. Customers should verify they are running software version 5.2.1 or later.
The recalled product
- Product
- LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
- Manufacturer
- Fresenius Kabi USA, LLC
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI 00811505030122 Software versions 5.0.1 and earlier.
Distribution
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