BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MRIDIUM MRI INFUSION STANDARD SET

    MDR report key: 25030959 · Received April 29, 2026

    Report

    Report Number
    MW5187414
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    April 17, 2026
    Report Date
    April 27, 2026
    Manufacturer
    IRADIMED CORPORATION
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    NURSING STAFF WERE ATTEMPTING TO USE IRADIMED CORPORATION MRI TUBING, REFERENCE NUMBER (B)(4) WHEN THE MEDICATION BEGAN TO SEEP THROUGH THE WALLS OF THE TUBING. THE MEDICATION THAT WAS BEING USED WAS PROPOFOL. THE NURSING STAFF TRIED THREE DIFFERENT SETS OF TUBING, ALL THE SAME LOT NUMBER AND ALL PRESENTED THE SAME ISSUE. THE NURSING STAFF USED A DIFFERENT SYSTEM AND TUBING TO COMPLETE THE TASK WITHOUT PATIENT HARM. PT: 4582. DEVICE: 3023, 1506, 1354. REF: MW5187415, MW5187416.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420671 MRIDIUM MRI INFUSION STANDARD SET PUMP, INFUSION FRN IRADIMED CORPORATION 1056 25E50N

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other