BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3100847 · Received May 8, 2013

    Report

    Report Number
    1061932-2013-00845
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED THAT THE "T" FITTING, WHICH IS ATTACHED TO THE RED STRIPE TUBING GOING THROUGH PINCH VALVE VL64, PIERCED A HOLE ON THE RED STRIPE TUBING ATTACHED TO THE DIFFERENTIAL SHEAR VALVE (CVL85/126). THE FSE REPLACED THE RED STRIPE TUBING ATTACHED TO THE DIFFERENTIAL SHEAR VALVE TO RESOLVE THE LEAK. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE "T" FITTING WHICH PIERCED A HOLE ON THE RED STRIPE TUBING ATTACHED TO THE DIFFERENTIAL SHEAR VALVE (CVL85/126). (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK UNDERNEATH THE SHEAR VALVES INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT 3 ML OF FLUID LEAKED AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201954 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1