Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0

FDA device recall Z-0002-2023 · posted 2022-10-06 · Terminated

Recall details

Recalling firm

Fresenius Kabi USA, LLC

Reason for recall

The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.

Action taken

On September 8, 2022, the company notified affected customers via phone call and emailed letter. Customers were instructed to do the following: 1. If a high priority Pump Problem alarm occurs, the LVP should be powered down by holding the power button for 10 seconds then releasing the power button so that the screen goes dark, then pressing the power button again to re-start the pump. Alternatively, if you have another LVP available, you may use it to resume infusion. 2. Inform potential users of the product within your organization of this notification. If your facility further distributes or transfers products amongst satellite sites or other locations, please disseminate this information accordingly. Fresenius Kabi has updated the software to rectify the condition. The updated software is currently available. Please schedule a service call at your earliest convenience to have it installed. Customer support: Ivenix_support@fresenius-kabi.com; 1-978-775-8100

Root cause

Software design

Status

Terminated

Product code

PHC

Quantity affected

4 instances

Distribution

Domestic distribution to NJ and WI.

Date initiated

2022-09-08

Date posted

2022-10-06

Date terminated

2024-09-10

Location

North Andover, MA

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