BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2904854 · Received January 9, 2013

    Report

    Report Number
    1061932-2013-00014
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 24, 2012
    Report Date
    December 24, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FLUID LEAK INSIDE THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE CUSTOMER INDICATED THAT THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT AND THE VOLUME OF THE LEAK WAS UNKNOWN. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE EVENT AND NO EXPOSURE OR INJURY WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE TO PATIENT TREATMENT AS A RESULT OF THE EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND OBSERVED A HOLE IN THE TUBING THROUGH PINCH VALVE PV49. THE FSE REPLACED THE TUBING AND REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES. FAILURE MODE WAS DETERMINED TO BE A HOLE IN THE TUBING THROUGH PINCH VALVE PV49.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12936 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1