BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2760365 · Received September 26, 2012

    Report

    Report Number
    1061932-2012-02445
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    September 4, 2012
    Report Date
    September 4, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE ON (B)(4) 2012. THE FSE INSPECTED THE INSTRUMENT AND FOUND THE DIFFERENTIAL MIXING CHAMBER WAS NOT DRAINING CAUSING OVERFLOW DURING THE RINSE CYCLE. THE FSE INDICATED THE DRAIN PINCH VALVE WAS BROKEN. THE FSE REPLACED THE PINCH VALVE AND THE ACTUATOR, AND VERIFIED OPERATION OF THE VALVE AND DRAINING WITH NO FURTHER LEAKS. THE CAUSE OF THE LEAK WAS BROKEN PINCH VALVE ASSOCIATED WITH DRAINING THE DIFFERENTIAL MIXING CHAMBER. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) AND STATED THERE WAS A LEAK OF CLEAR FLUID (10ML) BY THE RIGHT SIDE OF THE COULTER HMX HEMATOLOGY WITH AUTOLOADER ANALYZER AND OUTSIDE ON THE COUNTER. THE MSDS WAS NOT REVIEWED. THERE IS AN EXPOSURE CONTROL PLAN AT THE FACILITY. THE CUSTOMER WAS NOT WEARING GLOVES, BUT WAS NOT IN CONTACT WITH THE LIQUID. THERE WAS NO REPORT OF EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ONE SOUGHT MEDICAL ATTENTION. NO PATIENT RESULTS WERE AFFECTED AS A RESULT OF THE LEAK. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1