BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3191877 · Received June 27, 2013

    Report

    Report Number
    1061932-2013-01203
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    May 31, 2013
    Report Date
    May 31, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED A LEAK AT TUBINGS ASSOCIATED WITH PINCH VALVES VL4, VL6, VL12A, VL12B, AND VL57A. THE FSE WAS UNABLE TO IDENTIFY THE EXACT TUBING WHICH LEAKED AND PROCEEDED TO REPLACE ALL OF THE TUBINGS TO RESOLVE THE LEAK. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO TUBINGS ASSOCIATED WITH PINCH VALVES VL4, VL6, VL12A, VL12B, AND VL57A. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK UNDERNEATH THE COULTER LH 750 HEMATOLOGY ANALYZER AFTER RUNNING QC (QUALITY CONTROL). THE CUSTOMER INDICATED THAT APPROXIMATELY 10 ML OF FLUID LEAKED AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER STATED THAT THE INSTRUMENT GENERATED VACUUM DRIFT ERROR DURING THE EVENT. 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 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
    293439 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1