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Completed

LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004

FDA Recall Z-1282-2024 · Posted 2024-03-11

Recalling FirmFresenius Kabi USA, LLC
Recall StatusCompleted
Product CodeFRN
Date Initiated2022-09-16
Product Quantity3

Reason for Recall

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.

Firm 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.

Root Cause

Software design

Distribution Pattern

US Nationwide distribution in the states of WI and NJ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183311Ivenix Infusion System (IIS)Ivenix, Inc. · 2019-06-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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