Fresenius Kabi Recalls Ivenix Infusion Pump Software

Urgent Class I Recall Notice  

A crucial recall notice has been issued by Fresenius Kabi USA, LLC for the LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0, distributed between March 6, 2023, and March 20, 2024. The recall, initiated on March 7, 2024, is prompted by identified software anomalies that pose significant risks to patient safety. 

Product Details  

The Ivenix Infusion System serves as a vital tool in hospital and outpatient care environments, facilitating the controlled administration of fluids to patients through various delivery methods such as intravenous lines, arterial lines, epidurals, and subcutaneous delivery. These fluids encompass medications, blood products, and other necessary agents for the treatment of both adult and pediatric patients. 

Reason for Recall  

Fresenius Kabi USA, LLC has initiated a recall of the Ivenix Infusion System (IIS), LVP Software, due to multiple software anomalies that could potentially lead to serious patient harm or even fatalities. To address this critical issue, the company is releasing a new software version (5.9.1) for the Ivenix Large Volume Pump (LVP). 

Adverse Incidents  

Fortunately, there have been no reports of injuries or deaths associated with the identified software anomalies. However, the proactive recall and software update are essential measures to prevent any potential adverse incidents in the future. 

Who May be Affected  

Patients receiving treatment in healthcare settings utilizing the Ivenix Infusion System, as well as healthcare personnel responsible for administering fluids and medications, are directly impacted by this recall. 

Actions to Take  

Affected customers were promptly notified via an Urgent Medical Device Field Correction letter on March 7, 2024. To address the issue, customers are urged to: 

• Update all LVPs to software version 5.9.1 by contacting a Fresenius Kabi representative at 1-978-775-8100 for installation assistance. 
• Complete the Customer Reply Form provided with the letter to confirm receipt of the notification. 

Contact Information  

For further inquiries regarding this recall, customers in the U.S. can reach out to Fresenius Kabi at 1-978-775-8100. 

Conclusion  

The safety and well-being of patients receiving medical care are of paramount importance. Prompt action is required to ensure the timely implementation of the software update and mitigate any potential risks associated with the Ivenix Infusion System.  

Links 

Read the FDA recall announcement here.