BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 4108550 · Received September 22, 2014

    Report

    Report Number
    1061932-2014-02283
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 24, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE FOUND A PIN-SIZE HOLE IN TUBING THROUGH PINCH VALVE PV49. THE FSE REPLACED THE TUBING AND THE INSTRUMENT RAN WITHOUT LEAKS OR ERRORS. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN UNCONTAINED BLUE LIQUID LEAK OF APPROXIMATELY LESS THAN FIVE (5) ML FROM THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE CUSTOMER REPORTED THAT THE INSTRUMENT FAILED TO STARTUP WHEN THE LEAK WAS OBSERVED. THERE WERE NO REPORTS OF INJURIES, DIRECT PHYSICAL CONTACT WITH THE LEAK, ERRONEOUS RESULTS OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GOGGLES, GLOVES AND LABORATORY COAT WHEN THE LEAK OCCURRED. A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588017 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1