BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL HIGH EFFICIENCY LEUKOCYTE REDUCTION FILTER FOR PLATELET

    MDR report key: 193439 · Received September 25, 1998

    Report

    Report Number
    2647898-1998-00011
    Event Type
    Death
    Date Received
    September 25, 1998
    Date of Event
    August 11, 1998
    Report Date
    August 27, 1998
    Manufacturer
    PALL BIOMEDICAL,INC.
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS RECEIVING A PLATELET TRANSFUSION THROUGH THE DEVICE. THE TRANSFUSION WAS INITIATED AT 11:45. THE RN LEFT AND RETURNED AT 11:55. A CODE WAS CALLED AT 12:05. AT THIS TIME 140ML OF PLATELETS, OUT OF 195ML, HAD BEEN TRANSFUSED. CARDIAC/RESPIRATORY RESUSCITATION WAS UNABLE TO RESUSCITATE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL HIGH EFFICIENCY LEUKOCYTE REDUCTION FILTER FOR PLATELET LEUKOCYTE REDUCTION FILTER FOR PLATELETS CAK PALL BIOMEDICAL,INC. PXL8C 704207

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death