FDA Issues Warning Over Minnesota-Made Infusion Pumps for Regulatory Non-Compliance

The Food and Drug Administration (FDA) has issued a warning concerning infusion pumps manufactured in Minnesota by ICU Medical. The company, which acquired the Twin Cities-based Smiths Medical division in 2022, made significant modifications to their infusion pump designs without obtaining the necessary regulatory approvals. These changes, made after a previous recall linked to device malfunctions, have rendered the devices adulterated and misbranded under FDA standards.

ICU Medical's infusion pumps, including the Medfusion Model 4000 Syringe and the CADD Solis VIP Ambulatory infusion pump, have been in clearance since the early 2010s. However, the company failed to submit premarket notifications for substantial modifications that could impact device safety and effectiveness. The FDA pointed out that these unapproved changes can alter the devices’ performance, especially regarding delivery accuracy and alarm functionality, potentially posing risks such as under- or over-infusion, delayed therapy, or false alarms resulting in adverse health effects.

The devices in question were produced at a facility in the Twin Cities, following ICU’s acquisition of Smiths Medical. The FDA inspection, carried out between July 23 and August 9, 2024, identified the lack of proper regulatory filings. ICU Medical has not yet submitted a 510(k) application for these modifications, which are suspected to influence critical device functions. Moreover, the company’s updated software responds to recall issues but does not include the required FDA declaration of software status, further violating regulations.

ICU Medical has stated that it is working on completing the necessary 510(k) submissions and emphasizes its commitment to patient safety and regulatory compliance. The company reports ongoing investments to bolster quality control at the Minnesota facility.

The FDA cautions that failure to address these violations could lead to enforcement actions such as seizure, injunction, or civil penalties. This situation underscores the importance of strict adherence to device modification regulations to ensure patient safety and device efficacy.

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