BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL HIGH EFFICIENCY LEUKOCYTE REDUCTION FILTER FOR PLATELET

    MDR report key: 225060 · Received May 24, 1999

    Report

    Report Number
    2432733-1999-00005
    Event Type
    Other
    Date Received
    May 24, 1999
    Date of Event
    December 29, 1998
    Report Date
    January 17, 1999
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A CHRONICALLY ANEMIC PT WAS TRANSFUSED WITH IRRADIATED BLOOD PRODUCTS ON DECEMBER 17 AND 25 THROUGH THE FIRM'S LEUKOCYTE REDUCTION DEVICES FOR PLATELETS AND RED CELLS, WITHOUT INCIDENT. HISTORY OF PRIOR TRANSFUSIONS WAS NOT MADE AVAILABLE. IT WAS REPORTED THAT ON 12/29/1998 INITIATION OF A TRANSFUSION OF AN IRRADIATED PLATELET CONCENTRATE WAS FOLLOWED IN TWO (2) MINUTES BY SYMPTOMS OF HEADACHE, STOMACHACHE, AND URGE TO DEFECATE. UPON SITTING UP, THE PT TURNED PALE, DIAPHORESED AND REPEATEDLY YAWNED. THE TRANSFUSION WAS DISCONTINUED AND OXYGEN WAS ADMINISTERED. BLOOD PRESSUE WAS SYSTOLIC 40; DIASTOLIC, IMMEASURABLE. CARDIAC RATE WAS 50-60, SPO2 WAS 100% PER PULSE OXIMETER. THERAPY WITH FLUID AND STEROID WAS INITIATED, FOLLOWED BY DOPAMINE. THE PT THEN DEVELOPED ENCOPRESIS. AN HOUR AFTER THE INITIATION OF THE TRANSFUSION, THE PT'S CONSCIOUSNESS WAS NORMAL, WITH SYMPTOMS OF INTENSE BACK PAIN, BLOOD PRESSURE WAS 200/130MMHG. AFTER PENTAZOCINE IV WAS ADMINISTERED, THE PT WAS STABILIZED.

    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 PRODUCTS CO PXL8H UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention