BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOMICS FC 500 MPL FLOW CYTOMETER

    MDR report key: 4094477 · Received September 16, 2014

    Report

    Report Number
    1061932-2014-02386
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K071681
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND REPLACED THE PROBE SWITCHING VALVE (3-WAY VALVE) TO RESOLVE THE LEAK. (B)(4).

    Description of Event or Problem · 1

    A FIELD SERVICE ENGINEER (FSE) REPORTED THAT APPROXIMATELY 50 MICROLITERS OF FLUID LEAKED FROM THE PROBE SWITCHING VALVE (3-WAY VALVE) OF THE CYTOMICS FC 500 MPL FLOW CYTOMETER. THERE WERE NO ERRONEOUS PATIENT RESULTS GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE FLUID LEAKED INSIDE THE INSTRUMENT AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572285 CYTOMICS FC 500 MPL FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1