BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3233166 · Received July 18, 2013

    Report

    Report Number
    1061932-2013-01494
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND OBSERVED A LEAK FROM PORT 8 IN THE BSV (BLOOD SAMPLING VALVE) MID-SECTION DUE TO A DISCONNECTED TUBING. THE FSE REPLACED THE TUBING TO RESOLVE THE LEAK. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A DISCONNECTED TUBING AT PORT 8 IN THE BSV. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A CLEAR FLUID LEAK FROM THE LEFT AREA OF THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER REPORTED THAT THE VOLUME OF THE LEAK WAS APPROXIMATELY 50-100 ML AND THE LEAK WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF A LABORATORY COAT, GLOVES, AND A FACE SHIELD AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS PATIENT RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER STATED THAT THE INSTRUMENT DID NOT GENERATE ANY ERROR MESSAGES FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336280 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1