BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3120862 · Received May 20, 2013

    Report

    Report Number
    1061932-2013-00875
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 25, 2013
    Report Date
    April 25, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE VERIFIED THAT THE INSTRUMENTS BACKWASH CUP WAS NOT RETRACTING COMPLETELY. UPON FURTHER INSPECTION, THE FSE DISCOVERED THAT THE PROBE WAS BENT AND THERE WAS ALSO A LOOSE BLOOD SAMPLING VALVE (BSV) KNOB. AFTER BENDING THE PROBE BACK INTO PLACE AND TIGHTENING THE BSV KNOB THE BACK WASH CUP RETRACTED COMPLETELY AND THE LEAK STOPPED. THE FSE DOCUMENTED THAT THE LEAK WAS COMING FROM THE BSV DUE TO THE LOOSE BSV KNOB. THE FSE VERIFIED THE INSTRUMENT. FAILURE MODE FOR THE LEAK WAS LOOSE BSV KNOB. THE BACKWASH CUP WAS NOT RETRACTING COMPLETELY DUE TO THE PROBE BEING BENT. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE BACKWASH CUP WAS NOT RETRACTING ALL THE WAY UP AND THERE WAS APPROXIMATELY 1 ML LEAK OF CLEAR LIQUID CONTAINED WITHIN THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE INSTRUMENT WAS RUNNING A STARTUP WHEN THE LEAK WAS OBSERVED. THERE WAS NO ERROR MESSAGE GENERATED IN CONNECTION WITH THIS INCIDENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS NOT REVIEWED BY THE CUSTOMER. THERE IS AN EXPOSURE CONTROL OR RISK MANAGEMENT IN PLACE IN THE FACILITY. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE), CONSISTING OF GLOVES, GOGGLES, AND A LABORATORY COAT. THERE WAS NO EXPOSURE TO ANY OPEN WOUNDS OR MUCOUS MEMBRANES. NO PATIENT SAMPLES WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222075 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER N/A

    Patients

    Seq Age Sex Outcome Treatment
    1