BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL EZ PRIME REDUCTION FILTER FOR RED CELL TRANSFUSION

    MDR report key: 309433 · Received December 20, 2000

    Report

    Report Number
    2432733-2000-00004
    Event Type
    Other
    Date Received
    December 20, 2000
    Date of Event
    October 11, 2000
    Report Date
    November 6, 2000
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    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 AFTER A TRANSFUSION OF TWO UNITS OF ERYTHROCYTE MAP THROUGH THE DEVICE WAS STARTED, THE PT SOON COMPLAINED OF LINESS. THE PT'S HEART RATE WAS 72 BPM AND BLOOD PRESSURE WAS 54/30MMHG. THE TRANSFUSION WAS STOPPED AND THE PT WAS GIVEN 500ML'S OF PHYSIOLOGICAL SALINE ALONG WITH ATRIPINE SULFATE. THE BLOOD TYPE AND PREPARATION WERE RE-CHECKED, AND NO PROBLEMS WERE NOTED. HYDROCORTISONE SODIUM SUCCINATE WAS INTRAVENOUSLY ADMINISTERED AND OXYGEN INHALATION WAS STARTED. THE PT STARTED FEELING IMPROVEMENT AND BLOOD PRESSURE INCREASED TO 83/43MMHG. THE TRANSFUSION WAS RESTARTED SLOWLY. WITHIN 35 MINUTES THE PT'S BLOOD PRESSURE DECREASED TO 72/70MMHG AND ETILETRINE HYDROCHLORLE WAS INTRAVENOUSLY ADMINISTERED. 15 MINUTES LATER THE PT'S BLOOD PRESSURE WAS 76/38MMHG, AND A DRIP INFUSION OF D-SORBITOL LACTATED RINGER'S SOLUTION WAS CONDUCTED AND THE TRANSFUSION WAS COMPLETED. THIRTY MINUTES LATER THE PT'S BP HAD INCREASED TO 94/50MMHG AND BY THE NEXT DAY RETURNED TO 120/79. NO PT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL EZ PRIME REDUCTION FILTER FOR RED CELL TRANSFUSION LEUKOCYTE REDUCTION FILTER FOR RED CELL TRANSFUSION CAK PALL BIOMEDICAL PRODUCTS CO. RCEZ1V2 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention METHOTREXATE, CALCIUM FOLINATE 4 TIMES A DAY FOR 2| STARTED.| DAYS AND CYTARABINE TWICE A DAY FOR 2 DAYS WAS| MALIGNANT LYMPHOMA. CHEMOTHERAPY CONSISTING OF| THE PT WAS HOSPITALIZED FOR THE TREATMENT OF