BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALL BIOMEDICAL PRODUCTS CO

    MDR report key: 16856 · Received July 1, 1994

    Report

    Report Number
    16856
    Event Type
    Injury
    Date Received
    July 1, 1994
    Date of Event
    June 22, 1994
    Report Date
    June 23, 1994
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CARDIOPLEGIA LEUKOCYTE DEPLETING FILTER FORMED MANY BLOOD CLOTS. CLOTS WERE NOT SEEN UNTIL THE CIRCUIT WAS DRAINED POST-BYPASS. PT AND CIRCUIT WERE ADEQUATELY ANTICOAGULATED (TESTED EVERY 15 MINUTES BY ACTIVATED CLOTTING TIME TEST) CLOTS WERE ISOLATED TO THE FILTER ONLY. HAD CLOTS PASSED THROUGH THEY WOULD HAVE BEEN PERFUSED DIRECTLY INTO THE CORONARY SINUS. FILTER WAS SET-UP AND PRIMED ACCORDING TO MFR'S SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL BIOMEDICAL PRODUCTS CO CARDIOPLEGIA LEUKOCYTE DEPLETING FILTER CAK PALL BIOMEDICAL PRODUCTS CO. 292314

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Life Threatening