BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3093234 · Received May 5, 2013

    Report

    Report Number
    1061932-2013-00704
    Event Type
    Malfunction
    Date Received
    May 5, 2013
    Date of Event
    April 8, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FSE NOTICED THAT THE UPPER SHEATH RESTRICTOR TUBING RESTED AGAINST THE RIGHT SIDE OF THE ANALYZER AND LIQUID SLOWLY DRIPPED DOWN TO THE SENSOR DISTRIBUTION CARD JUMPERS CAUSING BED-NOT-LEVEL AND PROBE OBSTRUCTION ERRORS. THE FSE REMOVED THE JUMPERS AND DRIED THE JUMPERS USING PRESSURIZED CANNED AIR. THE FSE THEN REPLACED THE RESTRICTOR TUBING TO RESOLVE THE LEAK. TO RESOLVE THE PRESSURE ERRORS ISSUE, THE FSE REMOVED THE PRESSURE HOLD DOWN FITTING AT THE COMPRESSOR AND NOTICED THAT THE TUBING WAS CRACKED. THE FSE TRIMMED AND REINSTALLED THE PRESSURE TUBING, APPLYING THREADLOCK ON THE FITTING, TO RESOLVE THE PRESSURE ERRORS ISSUE. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE UPPER SHEATH RESTRICTOR TUBING. FAILURE MODE OF THE PRESSURE ERRORS IS A CRACKED TUBING AT THE COMPRESSOR WHICH GENERATED INSTRUMENT ERRORS AND HALTED SYSTEM OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED OBTAINING "60 PSI PRESSURE LOW" ERRORS INVOLVING THE COULTER LH 750 HEMATOLOGY ANALYZER. A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO TROUBLESHOOT THE PRESSURE ERRORS AND DISCOVERED APPROXIMATELY 100 ML OF DILUENT HAD LEAKED UNDER THE INSTRUMENT AND ONTO THE TABLE. THE FSE INDICATED THAT THE LEAK IS UNRELATED TO THE PRESSURE ERRORS. THE OPERATOR WAS WEARING A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND NO EXPOSURE OR INJURY 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
    195829 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1