Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for in

FDA device recall Z-3153-2024 · posted 2024-09-26 · Open, Classified

Recall details

Recalling firm

Fresenius Kabi USA, LLC

Reason for recall

The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.

Action taken

An URGENT Medical Device Field Correction Important Safety Update notification letter dated 8/30/24 was sent to customers. Required Actions for Users: 1. Please fill out the Customer Reply Form attached to this letter to acknowledge receipt. 2. If your facility further distributes or transfers products to satellite sites or other locations, please ask these locations to contact the email address on the Customer Reply Form so we can send notice to those satellites directly. 3. Install new software version (5.9.2) for the Ivenix Large Volume Pump (LVP). See details below. How To Obtain and Install Software Version 5.9.2 To request installation, please reach out promptly to your Fresenius Kabi representative (1-855- 354-6387 or Ivenix_support@fresenius-kabi.com). They will push the new software update to your pumps. When the LVP version 5.9.2 software update has been sent to the LVP, the following prompt appears before the LVP is shut down. Customer support - email Ivenix_su pport@fresenius-kabi.com Customer support - phone 1-855-354-6387 Normal business Hours are Monday through Friday 8:30 AM to 5 PM Eastern Time, After Hours Supported with Voicemail Messaging

Root cause

Software design

Status

Open, Classified

Product code

FRN

Quantity affected

17 units

Distribution

US Nationwide.

Date initiated

2024-08-30

Date posted

2024-09-26

Location

North Andover, MA

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