BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3233477 · Received July 18, 2013

    Report

    Report Number
    1061932-2013-01493
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER'S SITE. THE FSE DISCOVERED THAT THE PROBE WAS BENT AND THE PROBE RINSE BLOCK WAS WORN. THE FSE INDICATED THAT THE PROBE RINSE BLOCK WAS ALSO STUCK IN THE DOWN POSITION, PREVENTING THE BSV (BLOOD SAMPLING VALVE) FROM ROTATING PROPERLY. THE FSE STATED THAT THE CAUSE OF THE RINSE BLOCK GETTING STUCK WAS A BURR ON THE MECHANISM WHICH WAS STOPPING THE PISTON THAT CONTROLS THE MOVEMENT OF THE RINSE BLOCK. THE FSE REPLACED THE PROBE RINSE BLOCK STOP AND THE BENT PROBE TO RESOLVE THE ISSUES. THE FSE DID NOT SEE THE BATH OVERFLOW OR ANY VACUUM ERRORS WHILE AT THE CUSTOMER'S SITE. THE FSE STATED THAT THE CUSTOMER WAS UNAWARE OF THE RINSE BLOCK PROBLEM UNTIL THE FSE POINTED IT OUT TO THE CUSTOMER. THE FSE INDICATED THAT THE CUSTOMER MAY HAVE CONTINUED A CYCLE WITH THE BSV IN THE WRONG POSITION RESULTING IN THE BATH OVERFULL ERROR. RESULTS: FAILURE MODE OF THE EVENT IS ATTRIBUTED TO THE PROBE RINSE BLOCK WHICH WAS STUCK IN THE DOWN POSITION AND PREVENTED THE BSV FROM ROTATING PROPERLY DUE TO A BURR ON THE STOP MECHANISM; THE INSTRUMENT GENERATED BATH OVERFLOW ERRORS TO ALERT THE OPERATOR TO AN INSTRUMENT ISSUE. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NOT BEING ABLE TO REPORT ANY RESULTS FROM THE LH 500 HEMATOLOGY ANALYZER DUE TO FULL WBC (WHITE BLOOD CELL) AND RBC (RED BLOOD CELL) BATHS WHICH WOULD NOT DRAIN. THE CUSTOMER STATED THAT THE INSTRUMENT WAS GENERATING BATH OVERFLOW ERRORS AND THE CUSTOMER ALSO DISCOVERED A LEAK OF APPROXIMATELY 1 ML FROM THE PROBE WASH BLOCK OF THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, A LABORATORY COAT, AND EYE PROTECTION 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
    335145 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1