BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3171364 · Received June 14, 2013

    Report

    Report Number
    1061932-2013-01056
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED A LEAK IN THE SAMPLE LINE AT PINCH VALVE VL52. THE FSE STATED THAT THE SAMPLE LINE FROM THE DIFFERENTIAL MIXING CHAMBER TO THE FLOW CELL HAD A SMALL HOLE AND THE FSE REPLACED THE TUBING TO RESOLVE THE ISSUE. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE IS ATTRIBUTED TO A SMALL HOLE IN THE SAMPLE LINE AT VL52. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PINKISH FLUID LEAK OF OF ABOUT 1 ML FROM UNDER THE LASER AREA OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT FLUID LEAKED ONTO THE COUNTER BUT THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, PROTECTIVE EYEWEAR AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271258 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1