BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX ANALYZER WITH AUTOLOADER

    MDR report key: 2379192 · Received December 16, 2011

    Report

    Report Number
    1061932-2011-02635
    Event Type
    Malfunction
    Date Received
    December 16, 2011
    Date of Event
    November 18, 2011
    Report Date
    November 18, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT THERE WAS A BLUE LIQUID LEAK UNDERNEATH THE COULTER HMX ANALYZER WITH AUTOLOADER (HMX AUTOLOADER). CUSTOMER REPORTED THAT THEY COULD NOT PINPOINT THE SOURCE. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) OBSERVED THE HMX AUTOLOADER WAS LEAKING CLEANER. THE FSE FOUND THE SOURCE OF THE LEAK WAS A PINHOLE IN THE TUBING GOING THROUGH PINCH VALVE (PV) 43. PV43 IS THE PATH FOR THE WASTE FROM THE FOAM TRAP (FMT3) AND COMPLETE BLOOD COUNT (CBC) OVERFLOW VACUUM CHAMBER (VC8) INCLUDING LYSE S III. THE FSE REPLACED THE AFFECTED TUBING. THERE WAS NO FURTHER EVIDENCE OF LEAKING AFTER THE FSE REPLACED THE TUBING. THE FSE VERIFIED THE REPAIRS WERE PERFORMED PER ESTABLISHED PROCEDURES. THE FSE VERIFIED THE RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER HMX ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. HMX AUTOLOADER

    Patients

    Seq Age Sex Outcome Treatment
    1