BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3822264 · Received May 20, 2014

    Report

    Report Number
    1061932-2014-01114
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND A LEAK AT THE NEEDLE ASSEMBLY CAUSED BY THE NEEDLE BELLOWS OVERFLOWING. THE OVERFLOW WAS CAUSED BY PINCH VALVE (PV21) NOT ACTUATING. THE FSE REPLACED SOLENOID (LV29) 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 INSTRUMENT WAS IN SHUTDOWN WHEN THE LEAK WAS NOTICED. THE VOLUME OF THE LEAK WAS ABOUT 2 OZ. AND IT WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT OF LAB COAT, GLOVES, AND GOGGLES WHEN THE INSTRUMENT WAS CLEANED. 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
    300629 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1