BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL EZ PRIME HIGH EFFICIENCY LEUKOCYTE REDUCTION FILTER FOR

    MDR report key: 249534 · Received November 10, 1999

    Report

    Report Number
    2432733-1999-00015
    Event Type
    Other
    Date Received
    November 10, 1999
    Date of Event
    August 3, 1999
    Report Date
    October 4, 1999
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT SUFFERED AN ADVERSE REACTION WHILE BEING TRANSFUSED THROUGH THE DEVICE. THE PT REPORTEDLY DEVELOPED HYPERTENSION 15 MINUTES AFTER THE TRANSFUSION WAS INITIATED. THE TRANSFUSION WAS STOPPED AND THE PT WAS TREATED WITH BOLUS OF IV FLUIDS. WHEN THE INCIDENT OCCURRED, THE PT WAS BEING TREATED WITH VASOTEC AND LASIX DUE TO HYPERTENSION. THE PT BEING TREATED WAS IN VERY CRITICAL CONDITION, BUT HIS WAS THE ONLY HYPERTENSIVE EPISODE REPORTED ON THE PT'S RECORD. THE PT WAS FEBRILE DURING HOSPITALIZATION; THEREFORE, HE WAS ON ANTIBIOTICS BEFORE THE TRANSFUSION. THE PT LATER DIED ON 8/25/1999 DUE TO PNEUMONIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL EZ PRIME HIGH EFFICIENCY LEUKOCYTE REDUCTION FILTER FOR LEUKOCYTE REDUCTION FILTER CAK PALL BIOMEDICAL PRODUCTS CO RCEZ1K UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention