BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3241851 · Received July 22, 2013

    Report

    Report Number
    1061932-2013-01555
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE DISCOVERED A HOLE IN THE TUBING THROUGH PINCH VALVE PV43. PINCH VALVE PV43 OPENS DRAIN PATH FROM LOW VACUUM AND WASTE CHAMBER VC1. THE FSE REPLACED THE TUBING TO RESOLVE THE LEAK AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A HOLE IN THE TUBING THROUGH PINCH VALVE PV43. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK INSIDE THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE VOLUME OF THE LEAK WAS NOT SPECIFIED BUT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER NOTED THAT THE LEAK OCCURRED WHEN NOTHING WAS RUNNING ON THE INSTRUMENT AND THE CUSTOMER COULD NOT IDENTIFY THE SOURCE OF THE LEAK. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT DURING THE LEAK AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE INSTRUMENT DID NOT GENERATE AND ERROR MESSAGES FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339877 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1