BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2951194 · Received February 8, 2013

    Report

    Report Number
    1061932-2013-00186
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) OBSERVED THE FLUID LEAK ORIGINATED FROM THE BLOOD SAMPLING VALVE (BSV). THE ACTUATOR WAS NOT FUNCTIONING PROPERLY WHICH CAUSED THE BSV TO BE MISALIGNED, ALLOWING FLUID TO LEAK FROM THE BSV AND THE VACUUM TO DROP DURING SYSTEM STARTUP AND SHUTDOWN. THE FSE REPLACED THE ACTUATOR AND RESOLVED THE ISSUE. THE INSTRUMENT CONFORMED TO THE MANUFACTURER'S PUBLISHED SPECIFICATIONS AND WAS RETURNED TO NORMAL OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED SEVERAL DROPS OF FLUID LEAKED AT THE PROBE WIPE AND ONTO THE COUNTER DURING PATIENT SAMPLE ANALYSIS INVOLVING THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE CUSTOMER NOTED DRIED DEPOSITS AND FLUID OCCASIONALLY DRIPPED FROM THE PROBE WIPE BLOCK. THE CUSTOMER HAD ON PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AND DID NOT HAVE DIRECT CONTACT WITH THE FLUID. THERE WAS NO OPERATOR INJURY OR ADVERSE EFFECT ASSOCIATED WITH THIS EVENT. PATIENT RESULTS WERE NOT IMPACTED. THE CUSTOMER HAS AN EXPOSURE CONTROL PLAN AT THE FACILITY. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53549 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1