Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for

FDA device recall Z-2635-2023 · posted 2023-09-25 · Open, Classified

Recall details

Recalling firm

Fresenius Kabi USA, LLC

Reason for recall

Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set

Action taken

Ivenix initiated contact on 4/22/22/ via phone communicating the contents of the customer letter which was then emailed to each customer. Letter states reason for recall, health risk and action to take: Please note, the specified start-up flow accuracy of up to +8% is maintained throughout the extended start-up time; and the steady-state flow accuracy of +l-SYo of the LVP is not affected with this condition. There is no corrective action you need to take at this time. We believe that this condition is low risk in that the affected flow rate range is limited, the start'up flow rate accuracy is unaffected and still within specifications, and the clinical practice of monitoring patients while administering high alert drugs mitigates the risk. Ivenix is working on a software update to correct this condition. It will be available in approximately 60 days. We will inform you when that update is ready to install. If you have additional questions, please contact your Ivenix representative or support below. Customer support - email Customer support - phone suplrort@ivenix.com I-978-775-8TAA

Root cause

Device Design

Status

Open, Classified

Product code

FRN

Quantity affected

1344 pumps

Distribution

US Nationwide distribution in the states of NJ, WI.

Date initiated

2022-04-22

Date posted

2023-09-25

Location

North Andover, MA

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