BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IRADIMED

    MDR report key: 9450349 · Received December 11, 2019

    Report

    Report Number
    9450349
    Event Type
    Malfunction
    Date Received
    December 11, 2019
    Date of Event
    November 8, 2019
    Report Date
    November 20, 2019
    Manufacturer
    IRADIMED CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    RN WAS IN SERVICING ON THE MRIDIUM MRI PUMP WITH THE ED CLINICAL EDUCATOR AND WE WITNESSED THE IV FLUID LEAKING FROM CHAMBER A, SPECIFICALLY FROM THE FLOW-PREVENTER ON THE MRI MRI INFUSION EXTENSION SET 1000 SERIES (REF: (B)(4)) LOT # 023693. FLUID WAS OBSERVED LEAKING FROM TUBING THAT WHERE IT CONNECTS PROXIMALLY TO THE FLOW-PREVENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1249290 IRADIMED PUMP, INFUSION FRN IRADIMED CORP. 1058 023693

    Patients

    Seq Age Sex Outcome Treatment
    1