Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environme

FDA device recall Z-1019-2025 · posted 2025-02-04 · Open, Classified

Recall details

Recalling firm

Fresenius Kabi USA, LLC

Reason for recall

Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.

Action taken

Fresenius Kabi began notifying consignees on 01/10/2024 via emailed letter. Consignees were instructed to check if your device contains the affected software, review and become familiar with the temporary Risk Mitigation actions for each anomaly outlined in the letter and notify customers/personnel if the product was transferred or further distributed. Additionally, to facilitate the installation of the pump software, LVP SW 5.10, your facility must install the new Ivenix Infusion Management System (IMS) software version (5.2) on your IMS server and install the new software version (5.10) for the Ivenix Large Volume Pump (LVP). Please post this letter in areas that affected devices are stored and used such that users of this device are aware of the issues and recommended risk mitigation measures. Lastly, consignees were requested to complete and return the Customer Reply Form.

Root cause

Software Design Change

Status

Open, Classified

Product code

FRN

Quantity affected

23 systems

Distribution

US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.

Date initiated

2025-01-10

Date posted

2025-02-04

Location

North Andover, MA

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