BEUDAMED
    FDA Adverse Event Summary report: N

    LYMPHOCYTE SEPARATION MEDIUM

    MDR report key: 11471 · Received February 7, 1994

    Report

    Report Number
    MW4000274
    Date Received
    February 7, 1994
    Report Date
    March 5, 1993
    Manufacturer
    ORGANON TEKNIKA
    Product Code
    JCF
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    CONTAMINATED LOT OF LYMPHOCYTE SEPARATION MEDIUM. THIS MEDIUM IS USED AS A DENSITY GRADIENT FOR BONE MARROW. THE PROTOCOL USED FOR THE MANIPULATION OF THE BONE MARROW CALLS FOR ROUTINE CULTURES OF THE MARROW AT HARVEST, POST-PROCESSING, AND AT THAW. POSITIVE CULTURES ARE USUALLY FROM SKIN CONTAMINANTS, BUT THESE CULTURES WERE GROWING A PSEUDOMONAS STRAIN. THE FIRST OCCURRENCE WAS ON 12/9/92, WHEN TWO PTS HAD POSITIVE POST-PROCESSING CULTURES. THE WATERBATH AND PROCESSING PROCEDURES WERE CHECKED FOR CONTAMINATION, BUT WERE FOUND TO BE OKAY. ON 12/4/92, A NEW LOT OF LYMPHOCYTE PROCESSING MEDIA WAS OPENED; STARTED TO FILTER THE MEDIA ON 12/28/92 BEFORE USE. THE MEDIA WAS CULTURED (5 ML ALIQUOT) IN FICOL BROTH, BUT EXHIBITED NO GROWTH. STOPPED FILTERING THE MEDIA ON 1/19/93; FIVE PTS ON 2/2/93 HAD POSITIVE POST-PROCESSING CULTURES. THE MARROWS WERE ADMINISTERED TO THE PTS WITH NO ADVERSE REACTIONS, THE PTS WERE ON HIGH DOSES OF ANTIBIOTICS. THE TOTAL VOLUME OF THE MEDIA WAS PUT THROUGH A FILTER AND THEN CULTURED, THIS RESULTED IN POSITIVE GROWTH OF A PSEUDOMONAS STRAIN. DNA MAPPING OF THIS PSEUDOMONAS IS BEING DONE TO CONFIRM THAT IT IS THE SAME ORGANISM. LABEL STATES: FOR LAB USE ONLY, NOT APPROVED FOR HUMAN USE, AND FILTER STERILE SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LYMPHOCYTE SEPARATION MEDIUM JCF ORGANON TEKNIKA 102889

    Patients

    Seq Age Sex Outcome Treatment
    1 *