BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3230631 · Received July 16, 2013

    Report

    Report Number
    1061932-2013-01395
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 22, 2013
    Report Date
    June 23, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER'S SITE BUT THE FSE DID NOT FIND ANY LEAKS INSIDE THE INSTRUMENT. THE CUSTOMER REPORTED TO THE FSE THAT THE RBC BATH HAD BECOME LOOSE AND THE CUSTOMER HAD PUSHED THE BATH BACK INTO PLACE TO RESOLVE THE ISSUE. THE CUSTOMER STATED THAT THE INSTRUMENT WAS RUNNING WITHOUT ANY LEAKS AND PASSED ALL CONTROLS AFTER THE RBC BATH WAS SECURED. THE FSE ALSO VERIFIED THAT THE INSTRUMENT WAS RUNNING WITHOUT ANY LEAKS OR ERRORS. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO A LOOSE RBC BATH; THE INSTRUMENT OPERATED AS INTENDED BY FAILING PLT BACKGROUNDS TO ALERT THE OPERATOR OF AN INSTRUMENT ISSUE. RESULTS: LOOSE RBC BATH. CONCLUSION: THE ISSUE WAS RESOLVED BY THE CUSTOMER PRIOR TO THE FSE'S ARRIVAL. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK OF DROPLETS IN THE RBC (RED BLOOD CELL) BATH AREA OF THE COULTER LH 750 HEMATOLOGY ANALYZER WHILE TROUBLESHOOTING FOR INCOMPLETE HGB (HEMOGLOBIN). THE CUSTOMER STATED THAT THE INSTRUMENT WAS ALSO FAILING PLT (PLATELET) BACKGROUNDS (HIGH) WHEN THE LEAK WAS NOTICED. THE CUSTOMER INDICATED THAT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, EYE PROTECTION, AND A LABORATORY COAT AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE 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
    330050 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1