BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOMICS FC 500 MPL FLOW CYTOMETER

    MDR report key: 3819574 · Received May 19, 2014

    Report

    Report Number
    1061932-2014-01141
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Date of Event
    April 20, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K071681
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE FIELD SERVICE ENGINEER (FSE) PROCEEDED TO REPLACE THE VALVE AGAIN AND NO FURTHER LEAKS WERE NOTICED. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A DEFECTIVE VALVE. (B)(4).

    Description of Event or Problem · 1

    TWO (2) HOURS AFTER INSTALLATION OF A NEW SOLENOID VALVE, THE CUSTOMER REPORTED A LEAK FROM THE CYTOMICS FC 500 MPL FLOW CYTOMETER TO A FIELD SERVICE ENGINEER (FSE). THE FSE REPORTED THAT THE LEAK ORIGINATED FROM THE NEWLY INSTALLED SOLENOID VALVE ON THE INSTRUMENT. THE FSE STATED THAT THE VALVE WAS REPLACED DUE TO UNSTABLE PRESSURE ISSUE. THE FSE NOTED THAT SHEATH FLUID LEAKED AND WAS CONTAINED WITHIN THE MPL HOLDER AND WASH STATION. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT CONSISTING OF GLOVES, A SPECIAL MEDICAL GOWN, AND A PLASTIC FACE SHIELD DURING THE EVENT AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. ERRONEOUS RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297317 CYTOMICS FC 500 MPL FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1