BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL

    MDR report key: 11715645 · Received April 23, 2021

    Report

    Report Number
    11715645
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    April 6, 2021
    Report Date
    April 14, 2021
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT'S IV TUBING (SMALLBORE PRESSURE INF EXT SET) HAD BROKEN AND BLOOD BACKED UP INTO TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608805 ICU MEDICAL SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL, INC. A1152 5100468

    Patients

    Seq Age Sex Outcome Treatment
    1 730 DA