BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3203186 · Received July 2, 2013

    Report

    Report Number
    1061932-2013-01271
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED OBSERVING A CUT TUBING AT PINCH VALVE PV49 AND PROCEEDED TO REPLACE THE TUBING. THE CUSTOMER INDICATED THAT THE INSTRUMENT BEGAN TO MAKE A HISSING NOISE FOLLOWING THE TUBING REPLACEMENT AND THE CUSTOMER WAS INSTRUCTED BY A BECKMAN COULTER CTS (CUSTOMER TECHNICAL SUPPORT) OVER THE PHONE TO VERIFY THAT THE VACUUM AND FLUIDIC PATHWAYS WERE CLEAR. THE CUSTOMER NOTED A RESTRICTION AT THE BACKWASH PUMP AND PROCEEDED TO ADJUST THE PROBE BLOCK AS PER THE CTS' RECOMMENDATION. THE CUSTOMER NOTED NO FURTHER LEAKS AND THE INSTRUMENT RAN WITHOUT ANY ISSUES. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO A RESTRICTION AT THE BACKWASH PUMP CAUSING THE TUBING AT PINCH VALVE PV49 TO LEAK; THE CUSTOMER RESOLVED THE LEAK WITH THE HELP OF THE CTS OVER THE PHONE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHICH APPEARED TO BE CLEANER INVOLVING THE LH 500 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT THE INSTRUMENT GENERATED INTERMITTENT WBC (WHITE BLOOD CELL) VOTEOUTS DURING THE EVENT AND APPROXIMATELY 100 ML OF FLUID LEAKED ONTO THE COUNTERTOP. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES AND A LABORATORY COAT DURING 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
    301229 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1