BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL EZ PRIME HIGH EFFICIENCY LEUKOCYTE REDUCTION FILTER FOR

    MDR report key: 279435 · Received May 25, 2000

    Report

    Report Number
    2432733-2000-00001
    Event Type
    Other
    Date Received
    May 25, 2000
    Date of Event
    April 25, 2000
    Report Date
    April 25, 2000
    Manufacturer
    PALL BIOMEDICAL PRODUCTS CO.
    Product Code
    CAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OPEN HEART SURGERY THE PT REC'D A TRANSFUSION THROUGH THE DEVICE AT APPROXIMATELY 2:15 P.M. THE PT'S BLOOD PRESSURE IMMEDIATELY DROPPED FROM 94/52MMHG TO 50/38MMHG. A SECOND TRANSFUSION WAS GIVEN AT 6:30 P.M. AND THE PT'S BLOOD PRESSURE DROPPED FROM 129/69MMHG TO 117/62MMHG TO 88/46MMHG HALFWAY THROUGH THE TRANSFUSION. NO PT SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL EZ PRIME HIGH EFFICIENCY LEUKOCYTE REDUCTION FILTER FOR LEUKOCYTE REDUCTION FILTER FOR RED CELLS CAK PALL BIOMEDICAL PRODUCTS CO. RCEZ1T UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention