BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2990410 · Received March 5, 2013

    Report

    Report Number
    1061932-2013-00287
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND FOUND THAT THE VACUUM TRAP OF THE INSTRUMENT OVERFLOWED AND CAUSED THE LIQUID TO FLOOD THE PNEUMATIC POWER SUPPLY AND DAMAGE THE INSTRUMENT COMPUTER AND MONITOR. FSE REPLACED THE PNEUMATIC POWER SUPPLY AND THE INSTRUMENT COMPUTER. REPAIR WAS VERIFIED PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. THE CAUSE OF THE LEAK WAS THAT THE VACUUM TRAP OVERFLOWED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER (BEC) TO REPORT A LEAK INSIDE A COULTER HMX HEMATOLOGY ANALYZER. THE VOLUME OF THE LEAK WAS 50 ML. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES, GOGGLES AND A LAB COAT AT THE TIME OF THE EVENT. NO INJURY OR EXPOSURE WAS REPORTED. THERE WAS NO AFFECT TO PATIENT SAMPLES. NO ERRONEOUS RESULTS WERE GENERATED OR REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93484 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER AUTOMATED DIFFERENTIAL CELL COUNTER GKZ BECKMAN COULTER HMX AL NA

    Patients

    Seq Age Sex Outcome Treatment
    1