BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FUSA F80A (HF/PS/1.8/H)

    MDR report key: 250722 · Received November 17, 1999

    Report

    Report Number
    1713747-1999-00312
    Event Type
    Injury
    Date Received
    November 17, 1999
    Date of Event
    October 19, 1999
    Report Date
    October 21, 1999
    Manufacturer
    FRESENIUS
    Product Code
    KDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    MASSIVE BLOOD LEAK AT THE INITIATION OF TREATMENT. WHEN THE DIALYZER WAS EXAMINED THERE WAS NO O RING IN THE HEADER. ESTIMATED BLOOD LOSS 120CC. NO ADD'L ADVERSE EFFECT TO PTS. PT INFO = FEMALE. NO SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FUSA F80A (HF/PS/1.8/H) HIGH FLUX DIALYZER KDI FRESENIUS F80A 9EU226

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other