BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 4110138 · Received September 23, 2014

    Report

    Report Number
    1061932-2014-02394
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO ASSESS THE INSTRUMENT. THE FSE DISCOVERED TWO LEAKS, A LIQUID LEAK AND AN AIR LEAK INSIDE THE INSTRUMENT. THE FSE OBSERVED THE TUBING THROUGH PINCH VALVE (PV43) WAS CUT CAUSING THE LIQUID TO LEAK. THE FSE REPLACED THE TUBING THROUGH PINCH VALVE (PV43) AND THE LIQUID LEAK WAS REPAIRED. THE FSE ALSO OBSERVED A HOLE IN THE TUBING THROUGH PINCH VALVE (PV13) WHICH CAUSED THE AIR TO LEAK. THE FSE REPLACED THE TUBING THROUGH PINCH VALVE (PV13) AND THE INSTRUMENT PERFORMED WITHOUT ANY LEAKS OR ERRORS. THE FSE THEN PERFORMED VERIFICATION OF THE INSTRUMENT AND THE INSTRUMENT WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED APPROXIMATELY 5 TO 10 CUBIC CENTIMETERS OF CLEAR FLUID LEAKED UNDERNEATH THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER ALSO REPORTED THAT THE INSTRUMENT WAS GENERATING HEMOGLOBIN AND HEMATOCRIT (H&H) CHECK FAIL. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LAB COAT AT THE TIME OF THE OCCURRENCE. NO ERRONEOUS RESULTS WERE GENERATED IN CONNECTION WITH THE REPORTED EVENT. THERE WAS NO DEATH, INJURY, OF AFFECT TO USER OR CHANGE TO PATIENT TREATMENT ATTRIBUTED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589447 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1