BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ICU MEDICAL, INC.

    MDR report key: 518642 · Received March 17, 2004

    Report

    Report Number
    MW1031575
    Event Type
    Malfunction
    Date Received
    March 17, 2004
    Date of Event
    February 24, 2004
    Report Date
    March 15, 2004
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FILTER CHAMBER CRACKED AND LEAKED BLOOD ONTO FLOOR (FROM BLOOD TUBING). SQUEEZED THE FILTER CHAMBER A COUPLE OF TIMES SO THE BLOOD WOULD FILL ABOVE THE WHITE PLASTIC PIECE, THEN IT CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICU MEDICAL, INC. Y BLOOD TUBING BRZ ICU MEDICAL, INC. NA 192700

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other