BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL HIGH EFFICIENCY LEUKOCYTE REDUCTION FILTER FOR PLATELET

    MDR report key: 300451 · Received October 16, 2000

    Report

    Report Number
    2647898-2000-00016
    Event Type
    Other
    Date Received
    October 16, 2000
    Date of Event
    July 27, 2000
    Report Date
    August 14, 2000
    Manufacturer
    PALL BIOMEDICAL INC.
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT REC'D A PLATELET CONCENTRATE TRANSFUSION USING THE DEVICE AND DEVELOPED SYMPTOMS OF URTICARIA 10 MINUTES AFTER THE START OF THE TRANSFUSION. THE PT'S CONSCIOUSNESS BECAME CLOUDED; BLOOD PRESSURE BECAME IMPALPABLE, WITH A HEART RATE OF 80 BPM. THE TRANSFUSION WAS DISCONTINUED AND A DIAGNOSIS OF ANAPHYLAXIS WAS MADE; HYDROCORTISONE, ATROPINE AND FAMOTIDINE (ANTIHISTAMINE) WERE GIVEN, AND THE PT WAS INTUBATED. THE PT'S HEART RATE FELL TO 50 BPM, AND EPINEPHRINE WAS GIVEN SUBCUTANEOUSLY. WITHIN AN HOUR, CONSCIOUSNESS WAS RECOVERED, SPONTANEOUS BREATHING RESUMED, AND THE ENDOTRACHEAL TUBE WAS REMOVED. A HEAD CT SHOWED NO ABNORMALITY. A COMPLETE RECOVERY WAS MADE; NO PT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL HIGH EFFICIENCY LEUKOCYTE REDUCTION FILTER FOR PLATELET LEUKOCYTE REDUCTION FILTER FOR PLATELET TRANSFUSION CAK PALL BIOMEDICAL INC. PXL8V2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R