BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2803624 · Received October 24, 2012

    Report

    Report Number
    1061932-2012-02588
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 8, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND THE MANUAL PROBE TO BE BENT. FSE REPLACED THE MANUAL PROBE/BSV (BLOOD SAMPLING VALVE) ASSEMBLY WHICH RESOLVED THE LEAK. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE LEAK WAS A BENT PROBE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) STATING THAT THE RINSE BLOCK ON THEIR COULTER HMX AUTOLOADER LEAKED A FEW DROPS OF DILUENT ONTO THE COUNTER. THE CUSTOMER ALSO REPORTED THAT THE INITIAL STARTUP FAILED PLATELET (PLT) BACKGROUND AND UPON REPEAT, STARTUP PASSED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A GOWN, GLOVES AND GOGGLES. NO INJURY OR EXPOSURE WAS REPORTED. THE CUSTOMER HAD NOT RUN ANY PATIENT SAMPLES. NO PATIENT SAMPLES OR RESULTS WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER INC. HMX AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1