BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL LEUCOCYTE REMOVAL FILTER

    MDR report key: 394650 · Received May 15, 2002

    Report

    Report Number
    MW1025007
    Event Type
    Death
    Date Received
    May 15, 2002
    Date of Event
    May 6, 2002
    Manufacturer
    PALL BIOMEDICAL
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Description of Event or Problem · 1

    RPTR STATED THAT THE PRODUCT WAS USED ON THE PT DURING OPEN HEART SURGERY. THE PT EXPERIENCED A DRASTIC DROP IN BLOOD PRESSURE DURING THE USE OF THE DEVICE. WHEN THE TRANSFUSION WAS STOPPED, THE PT'S BLOOD PRESSURE RETURNED TO NORMAL. ON THE OTHER HAND, WHEN THE TRANSFUSION (USING THE DEVICE) WAS RESTARTED, THE PT'S BLOOD PRESSURE DROPPED AGAIN. THE TRANSFUSION WAS THEN TOTALLY DISCONTINUED AND THE PT MADE IT THROUGH THE SURGERY SUCCESSFULLY. THE PT DID DIE EIGHT DAYS LATER, HOWEVER, DUE TO OTHER FACTORS UNRELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL LEUCOCYTE REMOVAL FILTER BLOOD FILTER CAK PALL BIOMEDICAL * 128306

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death