BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3781301 · Received April 30, 2014

    Report

    Report Number
    1061932-2014-00964
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 7, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, BECKMAN COULTER FIELD SERVICE ENGINEER EVALUATED THE INSTRUMENT AND FOUND DILUENT LEAKING FROM THE VENT LINE AT PINCH VALVE PV22. THE FSE STATED THAT SOLENOID LV28 WAS NOT FIRING CAUSING PV22 NOT TO OPEN. PV22 PROVIDES RINSE PATH FROM NEEDLE TO NEEDLE VENT CHAMBER VC4 IN ITS NORMAL STATE AND OPENS PATH FROM PRESSURIZED DILUENT FOR NEEDLE RINSE IN ITS OPERATED STATE. THE FSE REPLACED THE DILUTER INTERFACE CARD (PART # 7000024R) AND I/O (PART # 7000023R) TO RESOLVE THE ISSUE AND THE INSTRUMENT RAN WITHOUT ANY LEAKS. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK IN THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE LEAK WAS FROM THE RIGHT SIDE OF THE ANALYZER IN THE AREA OF THE PUMP MODULE WITHIN THE INSTRUMENT. THE VOLUME OF THE LEAK WAS ABOUT 10 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AND A LAB COAT WHEN THE LEAK WAS DISCOVERED. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO THE USER OR PATIENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259025 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1