BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LH 500 HEMATOLOGY ANALYZER

    MDR report key: 3241869 · Received July 22, 2013

    Report

    Report Number
    1061932-2013-01556
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    July 5, 2013
    Report Date
    July 5, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K032000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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 A HOLE IN THE TUBING AT PINCH VALVE PV37 AND PROCEEDED TO REPLACE THE TUBING TO RESOLVE THE ISSUE. IN INSTRUMENT NORMAL STATE, PINCH VALVE PV37 PROVIDES OPEN VACUUM AND CLEANING AGENT PATH TO PM10 (CLEANING AGENT PUMP) AND PROVIDES OPEN PRESSURIZED DILUENT PATH FROM SHEATH TANK TO MANIFOLD MF11. IN OPERATED STATE, PINCH VALVE PV37 OPENS 30 PSI PRESSURE PATH TO PM10 AND ALSO OPENS CLEANING AGENT PATH TO PRESSURIZED DILUENT TO MANIFOLD MF11. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A HOLE IN THE TUBING AT PINCH VALVE PV37. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT APPROXIMATELY 2 ML OF BLUE LIQUID LEAKED FROM THE LH 500 HEMATOLOGY ANALYZER AND ONTO THE COUNTERTOP DURING INSTRUMENT START UP. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, GOGGLES, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341884 LH 500 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1