BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3092604 · Received May 3, 2013

    Report

    Report Number
    1061932-2013-00732
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND THAT THE LEAK WAS COMING FROM THE BSV (BLOOD SAMPLING VALVE) ASSEMBLY. FSE TOOK APART THE BSV ASSEMBLY, CLEANED IT AND REATTACHED BUT IT CONTINUED TO LEAK. THE FSE THEN REPLACED THE BSV ASSEMBLY WHICH RESOLVED THE LEAK AND THE UNIT WAS CONFIRMED AS OPERATIONAL. THE CAUSE OF THE LEAK IS ATTRIBUTED TO THE BSV ASSEMBLY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A LEAK IN A COULTER HMX HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS UNKNOWN. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) INCLUDING A LABCOAT AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. THERE WAS NO AFFECT TO PATIENT SAMPLES OR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194100 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER HMX AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1