Fresenius Kabi USA, LLC Recall 93968
Description: LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Fresenius Kabi USA, LLC Recall 93968 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1283-2024 |
| Event ID | 93968 |
| Event Description | LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 |
| Product Type | Devices |
| Distribution | US Nationwide distribution to the states of CA, CO, NJ, WI, UT. |
| Quantity | 6 US |
| Recall Reason | 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. |
| Device Classification | 20240320 |
| Device Code Info | UDI-DI 00811505030122 Software versions 5.2.1/5.2.2 |
| Center Classification Date | 20240311 |
| Recall Initiation Date | 20230510 |
| Recalling Firm | Fresenius Kabi USA, LLC |
| Initial Notification | Other |
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