BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 19749367 · Received July 16, 2024

    Report

    Report Number
    19749367
    Event Type
    Malfunction
    Date Received
    July 16, 2024
    Date of Event
    March 4, 2024
    Report Date
    April 24, 2024
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    WHEN MAKING A HAZARDOUS CHEMOTHERAPY, THE CHEMOCLAVE FELL APART RESULTING IN DRUG LOSS AND SPILLAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722976 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. CL2000SCP 13850234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown