BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3241870 · Received July 22, 2013

    Report

    Report Number
    1061932-2013-01557
    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
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 TUBING WITH A PIN HOLE AT PORT 8 (TUBING 208) OF BSV AND PROCEEDED TO REPLACE THE TUBING TO RESOLVE THE LEAK. THE FSE ALSO OBSERVED HIGH DIFFERENTIAL PRESSURE ABOVE LIMIT ERRORS DURING VERIFICATION OF DIFFERENTIAL PRESSURE. THE FSE FOUND THAT THE DIFFERENTIAL PRESSURE REGULATOR EQUALED TO 30 PSI AND WAS UNABLE TO REGULATE THE PRESSURE BY ADJUSTING THE REGULATOR. THE FSE DETERMINED THAT THE DIFFERENTIAL PRESSURE REGULATOR (RG4) WAS FAULTY AND ORDERED A REPLACEMENT. THE FSE RETURNED TO THE CUSTOMER'S SITE AND REPLACED THE FAULTY REGULATOR TO RESOLVE THE DIFFERENTIAL SAMPLE HIGH PRESSURE ERRORS. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A PIN HOLE AT PORT 8 (TUBING 208) ON THE BSV; THE INSTRUMENT GENERATED HIGH RESULTS QC RESULTS FOR RBC AND PLT TO ALERT THE OPERATOR TO AN INSTRUMENT ISSUE. FAILURE MODE OF THE DIFFERENTIAL PRESSURE ERRORS WHICH WAS GENERATED DURING THE FSE'S EVALUATION OF THE INSTRUMENT IS ATTRIBUTED TO A FAULTY DIFFERENTIAL PRESSURE REGULATOR. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED MORE THAN 10 ML OF CLEAR FLUID LEAKED FROM BLOOD SAMPLING VALVE (BSV) TUBING 208 OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER INDICATED THAT TUBING 208 OF BSV HAD A PIN HOLE WHICH CAUSED THE LEAK. THE CUSTOMER WAS TROUBLESHOOTING FOR FAILING QUALITY CONTROL (QC) RESULTS WITH HIGH RED BLOOD CELLS (RBC) AND PLATELETS (PLT) PRIOR TO NOTICING THE LEAK. 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
    341324 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1