BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 780 HEMATOLOGY ANALYZER

    MDR report key: 3212145 · Received July 8, 2013

    Report

    Report Number
    1061932-2013-01328
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K061616
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND OBSERVED A LEAK AT THE DIFFERENTIAL SHEAR VALVE. THE FSE DISCOVERED THAT THE RED STRIPE TUBING CONNECTING THE BSV (BLOOD SAMPLING VALVE) TO THE T-FITTING HAD A SMALL HOLE. THE FSE REPLACED THE TUBING TO RESOLVED THE LEAK AND CLEANED THE DIFFERENTIAL SHEAR VALVE AND DRIP TRAY. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND NO FURTHER EVIDENCE OF LEAKS WERE OBSERVED. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A HOLE IN THE TUBING CONNECTING THE BSV TO THE T-FITTING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE DIFFERENTIAL SHEAR VALVE WHILE PERFORMING WEEKLY MAINTENANCE ON THE COULTER LH 780 HEMATOLOGY ANALYZER'S SHEAR VALVES. THE CUSTOMER INDICATED THAT A FEW DROPS OF FLUID LEAKED BUT WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES 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. THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES OR FLAGS AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309290 COULTER® LH 780 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1