BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 5421352 · Received February 9, 2016

    Report

    Report Number
    1061932-2016-00153
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Date of Event
    January 12, 2016
    Report Date
    January 12, 2016
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 01/12/2016. THE FSE FOUND THAT THE BLOOD SAMPLING VALVE (BSV) WAS DEFECTIVE. THE FSE REPLACED THE BSV, WHICH REPAIRED THE LEAK. THE REPAIRS WERE VERIFIED BY THE FSE.(B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM THE COULTER HMX ANALYZER WITH AUTOLOADER. THE CUSTOMER ALSO REPORTED THAT THE INTERMITTENT BACKWASH ERRORS WHEN THE LEAK OCCURED. THE VOLUME OF THE LEAK WAS ABOUT 15 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AT THE TIME OF THE OCCURRENCE AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. ERRONEOUS PATIENT RESULTS WERE NOT 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
    83301 COULTER HMX ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1