BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL EBDS

    MDR report key: 546798 · Received September 29, 2004

    Report

    Report Number
    2013342-2004-00007
    Event Type
    Other
    Date Received
    September 29, 2004
    Date of Event
    August 27, 2004
    Report Date
    September 3, 2004
    Manufacturer
    PALL MEDSEP
    Product Code
    MZC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE (THE PALL BDS OXYGEN ANALYZER) TESTED A PLATELET, APHERSIS UNIT AS A FALSE NEGATIVE FOR BACTERIA. THE UNIT WAS TESTED AND THEN SPLIT INTO TWO (2) PRODUCTS (SEE ALSO 2013342-2004-00006). THE TWO (2) PRODUCTS WERE DISTRIBUTED AND TRANSFUSED TO TWO (2) DIFFERENT PTS. BOTH PTS HAD AN INCREASE IN TEMPERATURE AND PULSE. THEY ALSO EXPERIENCED CHILLS. THE UNITS WERE SUSPECTED TO BE CONTAMINATED WITH BACTERIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALL EBDS BACTERIAL DETECTION SYSTEM FOR PLATELET TRANSFUSION PRODUCTS MZC PALL MEDSEP BDS02/400-03 SET L/N 0400995

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization