BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 3061229 · Received April 16, 2013

    Report

    Report Number
    1061932-2013-00572
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND OBSERVED FLUID BEING PULLED INTO THE COMPRESSOR (WHICH IS PART OF THE PNEUMATIC POWER SUPPLY ASSEMBLY). THE FSE REPLACED THE PNEUMATIC ASSEMBLY WHICH RESOLVED THE LEAK. THE FSE SET THE PRESSURES AND VACUUM READINGS TO SPECIFICATIONS. SERVICE ACTIVITY PERFORMED WAS VERIFIED TO MEET THE SPECIFIED REQUIREMENTS PER ESTABLISHED PROCEDURES. THE CAUSE OF THE LEAK IS ATTRIBUTED TO AN OVERFLOW OF THE VACUUM TRAP INTO THE PNEUMATIC POWER SUPPLY ASSEMBLY. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A CLENZ (CLEANER) LEAK OF APPROXIMATELY 50ML FROM THE VACUUM TRAP OF A COULTER HMX HEMATOLOGY ANALYZER. THE CUSTOMER DID NOT REPORT ANY INSTRUMENT GENERATED ERROR MESSAGES HOWEVER THE INSTRUMENT WAS LOCKED IN 'DILUTING' MODE WHEN THE LEAK WAS DISCOVERED. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABCOAT AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. THERE WAS NO AFFECT TO PATIENT SAMPLES OR RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    161913 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER HMX AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1