Fresenius Kabi Recalls Ivenix Infusion Pump Software Over Serious Safety Concerns

Fresenius Kabi USA, LLC has issued a critical correction notice regarding the Ivenix Infusion System’s Large Volume Pump (LVP) software. This recall, classified as Class I by the FDA, signifies the most severe type, as usage of the affected devices may lead to severe injuries or even fatalities. However, it’s essential to clarify that this recall is a correction, not a product removal.

The recalled product is specifically the LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0, identified by the product code FRN. Distribution of this software occurred between March 6, 2023, and March 20, 2024, with only 17 devices recalled in the United States. The firm initiated the recall on March 7, 2024.

The Ivenix Infusion System serves a crucial role in hospitals and outpatient care settings, facilitating the controlled administration of fluids to patients via various delivery methods such as intravenous lines, arterial lines, epidurals, and subcutaneous delivery. These fluids encompass medications, blood products, and other therapeutic agents necessary for treating patients across all age groups, from neonates to adults.

The reason behind the recall stems from multiple software anomalies within the Ivenix Infusion System’s LVP Software, which pose a significant risk of causing severe harm or even death to patients. In response, Fresenius Kabi is deploying a corrective measure in the form of a software update, introducing version 5.9.1 for the Ivenix Large Volume Pump.

Crucially, there have been no reported instances of injuries or fatalities associated with these software anomalies, which emphasizes the proactive nature of the recall in preventing potential harm.

Those potentially affected by this recall include individuals receiving treatment in healthcare settings utilizing the Ivenix Infusion System, as well as healthcare personnel responsible for administering blood and medications via these systems.

To address this issue, Fresenius Kabi has issued an Urgent Medical Device Field Correction on March 7, 2024, notifying all affected customers. The corrective action includes updating all LVPs to software version 5.9.1, which customers can arrange by contacting a Fresenius Kabi representative at 1-978-775-8100. Additionally, customers are requested to complete the enclosed Customer Reply Form to confirm receipt of the notification.

For customers in the United States seeking further information or assistance regarding this recall, Fresenius Kabi can be contacted directly at 1-978-775-8100.

In light of this recall, it’s crucial for healthcare providers and facilities to promptly undertake the necessary actions outlined by Fresenius Kabi to ensure the safety and well-being of patients relying on infusion systems for their medical care.

In conclusion, while recalls of medical devices are concerning, the proactive measures taken by Fresenius Kabi underscore their commitment to patient safety and regulatory compliance. By promptly addressing the identified software anomalies, they aim to mitigate potential risks and uphold the integrity of their products in healthcare settings.

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