Recall Z-1282-2024 ยท FRN Pump, Infusion
Fresenius Kabi USA, LLC
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
| Date | Mar 11, 2024 (initiated Sep 16, 2022) |
| Status | Completed |
| Reason | Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022. |
| Root cause | Software design |
| Action | The issue was resolved through an update of the software to Version 5.2.1, which was installed at customer sites in September 2022. The firm did not issue a customer letter at the time. According to the firm, this issue has been resolved in all fielded product. There have been two subsequent software upgrades since Version 5.2.1 was released. Consignees are now on v 5.8.0. |
| Quantity | 3 |
| Distribution | US Nationwide distribution in the states of WI and NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183311 | Ivenix Infusion System (IIS) Ivenix, Inc., Jun 7, 2019 |