BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALL HIGH EFFICIENCY RAPID FLOW LEUKOCYTE REMOVAL FILTER

    MDR report key: 558913 · Received May 7, 2004

    Report

    Report Number
    2647898-2004-00001
    Event Type
    Malfunction
    Date Received
    May 7, 2004
    Date of Event
    April 12, 2004
    Report Date
    April 12, 2004
    Manufacturer
    PALL BIOMEDICAL, INC.
    Product Code
    CAK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOTY-FIVE MINUTES AFTER INITIATION OF A 3ML/MIN RED CELL TRANSFUSION, THE PT (DIAGNOSED WITH AML) EXPERIENCED A TRANSFUSION REACTION, CHARACTERIZED BY HYPOTENSION (FROM 150/100 MMHG TO 50 MMHG SYSTOLIC) AND HYPOXIA (SP O2) =89.5%, DYSPNEA, INCONTINENCE, AND UNRESPONSIVENESS. EDEMA WAS PRESENT IN BOTH EYELIDS. THIRTY-FIVE (35) MINUTES AFTER RESUSCITATION WITH RINGERS LACTATE, HYDROCORTISONE, AND OXYGEN, BP ROSE TO 104/70 AND THE PT RECOVERED CONSCIOUSNESS. TWENTY-FIVE (25) MINUTES LATER, BP HAD RECOVERED TO 114/70 MMHG, SP O2 WAS 99% AND DYSPNEA WAS RESOLVED. WITHIN ANOTHER 45 MINUTES BP REACHED 127/80, SP O2= 100%. NO SEQUELAE WERE NOTED AT THREE DAYS AFTER THE TRANSFUSION REACTION. THE REPORTER FELT THE RED CELLS AND/OR BEDSIDE LEUKOREDUCTION DEVICE MAY HAVE CONTRIBUTED TO THIS TRANSFUSION REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL HIGH EFFICIENCY RAPID FLOW LEUKOCYTE REMOVAL FILTER LEUKOCYTE REDUCTION FOR RED CELLS CAK PALL BIOMEDICAL, INC. RC400VSP UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *