BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 4215527 · Received October 30, 2014

    Report

    Report Number
    1061932-2014-02658
    Event Type
    Malfunction
    Date Received
    October 30, 2014
    Date of Event
    October 3, 2014
    Report Date
    October 3, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) FOUND THAT THE PROBE WIPE RINSE BLOCK WAS MISALIGNED WHICH WAS PREVENTING THE PROBE WIPE TO MOVE PROPERLY CAUSING THE LEAK. THE FSE REALIGNED THE PROBE RINSE BLOCK RESOLVING THE ISSUE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CLEAR LEAK FROM THE INSIDE OF THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER AND AN UNCONTAINED LEAK ONTO THE TABLETOP. THE VOLUME OF LIQUID WAS UNDETERMINED BY THE CUSTOMER. THERE WERE NO REPORTS OF INJURIES, ERRONEOUS RESULTS, DIRECT PHYSICAL CONTACT WITH THE LEAK OR CHANGE TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE INSTRUMENT OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, GLOVES AND EYE PROTECTION DURING THE EVENT. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    697190 COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1