BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 2944688 · Received February 5, 2013

    Report

    Report Number
    1061932-2013-00163
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 13, 2013
    Report Date
    January 13, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    TROUBLESHOOTING WAS PERFORMED BY THE CUSTOMER AND ISSUE WAS RESOLVED BY REPLACING THE AFFECTED TUBING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CLEAR FLUID LEAK DRIPPING FROM UNDER THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE VOLUME OF THE LEAK WAS APPROXIMATELY 5 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) CALLED THE CUSTOMER TO SCHEDULE AN EVALUATION OF THE INSTRUMENT BUT THE CUSTOMER INDICATED THAT THE ISSUE HAD BEEN RESOLVED. THE CUSTOMER LOCATED THE SOURCE OF THE LEAK TO BE COMING FROM THE TUBING AT PINCH VALVE (VL59) AND PROCEEDED TO REPLACE THE TUBING. THE CUSTOMER HAD NOT REPORTED A RECURRENCE OF THE EVENT TO DATE AND ISSUE WAS RESOLVED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47837 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1