BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3253429 · Received July 29, 2013

    Report

    Report Number
    1061932-2013-01614
    Event Type
    Malfunction
    Date Received
    July 29, 2013
    Date of Event
    July 9, 2013
    Report Date
    July 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. THE FSE DISCOVERED DILUENT COMING OUT OF THE ASPIRATION PROBE WHEN THE BLOOD SAMPLING VALVE (BSV) WOULD CYCLE AND PREPARE TO CLEAN THE PROBE. THE FSE REMOVED THE BSV TO CLEAN THE PATHWAYS AND OBSERVED THAT THE BSV HAD BEEN RUBBING AND WAS BEGINNING TO WEAR. THE FSE PROCEEDED TO REPLACE THE BSV AND ITS ACTUATOR TO RESOLVE THE LEAK. THE FSE ALSO NOTICED THAT PINCH VALVE PV15 WAS PARTIALLY CRACKED WHERE IT MOUNTS BUT WAS STILL FUNCTIONING. THE FSE REPLACED PINCH VALVE PV15 AND PV14. PINCH VALVE PV14 AND PV15 CONTROL THE ASPIRATION PATH FROM THE BSV TO THE PRIMARY MODE ASPIRATION PUMP. THE REPLACEMENT OF PV15 WAS UNRELATED TO THE REPORTED LEAK AND REPLACEMENT OF PV14 WAS DONE AS A PREVENTATIVE MEASURE. THE FSE VERIFIED REPAIRS PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO THE WORN BSV AND ITS ACTUATOR. THE FSE ALSO REPLACED PINCH VALVE PV15 AS IT WAS CRACKED. BECKMAN COULTER INTERNAL IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED CLEAR FLUID LEAKED FROM THE BLOOD SAMPLING VALVE (BSV) OF THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER WHEN SWITCHING TO MANUAL MODE. THE CUSTOMER INDICATED THAT LESS THAN 1 ML OF FLUID LEAKED AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES DURING THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER REPORTED THAT THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES WHEN THE LEAK WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353748 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1