BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3141220 · Received June 3, 2013

    Report

    Report Number
    1061932-2013-00939
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND DISCOVERED THE LEAK COMING FROM A CUT TUBING THROUGH PINCH VALVE PV49. THE FSE PROCEEDED TO REPLACE THE TUBING TO RESOLVE THE LEAK. THE FSE ALSO DISCOVERED THAT THE RADIO FREQUENCY (RF) BOX OF THE TRIPLE TRANSDUCER MODULE (TTM) WAS BROKEN AND CAUSED THE INSTRUMENT TO GENERATE THE 'DIFF VOTEOUTS' ON CONTROLS. THE FSE REPLACED THE RF BOX AND THE INSTRUMENT PASSED ALL CONTROLS. REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED SPECIFICATIONS. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A CUT TUBING AT PINCH VALVE PV49 AND FAILURE MODE OF THE 'DIFF VOTEOUTS' ON CONTROLS IS ATTRIBUTED TO A DEFECTIVE RF BOX; THE INSTRUMENT OPERATED AS INTENDED BY GENERATING 'DIFF VOTEOUTS' ON CONTROLS TO ALERT THE OPERATOR TO AN INSTRUMENT PROBLEM. RESULTS: RF BOX. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK INSIDE THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER AND STATED THAT THE INSTRUMENT GENERATED 'DIFF VOTEOUTS' ON CONTROLS WHEN THE LEAK WAS NOTICED. THE CUSTOMER INDICATED THAT APPROXIMATELY 1 ML OF FLUID LEAKED AND WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT AND GLOVES AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243006 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1