BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALL PURECELL RAPID FLOW HIGH EFFICIENCY LEUKOCYTE REDUCTION

    MDR report key: 249157 · Received November 10, 1999

    Report

    Report Number
    2647898-1999-00013
    Event Type
    Death
    Date Received
    November 10, 1999
    Date of Event
    October 8, 1999
    Report Date
    October 13, 1999
    Manufacturer
    PALL BIOMEDICAL INC.
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN 80 YR OLD PT WAS SENT FROM A NURSING HOME TO THE FACILITY IN ORDER TO RECEIVE AN OUTPATIENT TRANSFUSION DUE TO ANEMIA. AFTER THE FIRST UNIT OF PACKED RED CELLS (OF TWO SCHEDULED) WAS ALMOST COMPLETE, THE PT EXHIBITED SYMPTOMS ("TBD"). OVER THE COURSE OF 30 MINS THE PT DETERIORATED AND PASSED AWAY. AN AUTOPSY WILL NOT BE PERFORMED. THE HOSP HAS NOTIFIED THE FDA OF THE DEATH. THE FDA HAD REQUESTED THE HOSP TO NOTIFY THE CO IN ORDER TO GENERATE A MEDWATCH REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL PURECELL RAPID FLOW HIGH EFFICIENCY LEUKOCYTE REDUCTION LEUKOCYTE REDUCTION FILTER CAK PALL BIOMEDICAL INC. RCQT 919512

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death