BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOMICS FC 500 MPL FLOW CYTOMETER

    MDR report key: 4965937 · Received August 4, 2015

    Report

    Report Number
    1061932-2015-01241
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 9, 2015
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K071681
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 07/9/2015. THE FSE FOUND THAT THE SYRINGE WAS DAMAGED AND WAS CAUSING THE LEAK. THE FSE REPLACED THE SYRINGE, WHICH REPAIRED THE LEAK. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(6).

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT ON 07/9/2015. THE FSE FOUND THAT THE SYRINGE WAS DAMAGED AND WAS CAUSING THE LEAK. THE FSE REPLACED THE SYRINGE, WHICH REPAIRED THE LEAK. THE REPAIRS WERE VERIFIED PER ESTABLISHED PROCEDURES. (B)(6).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM SHEATH TANK TUBING OF THE CYTOMICS FC 500 MPL FLOW CYTOMETER. THE INSTRUMENT WAS FAILING THE FLOWCHECK WHEN THE LEAK WAS NOTICED. THE VOLUME OF THE LEAK WAS ABOUT 0.5 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE OCCURRENCE AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. ERRONEOUS PATIENT RESULTS WERE NOT GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM SHEATH TANK TUBING OF THE CYTOMICS FC 500 MPL FLOW CYTOMETER. THE INSTRUMENT WAS FAILING THE FLOWCHECK WHEN THE LEAK WAS NOTICED. THE VOLUME OF THE LEAK WAS ABOUT 0.5 ML AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF GLOVES AND A LABORATORY COAT AT THE TIME OF THE OCCURRENCE AND THERE WAS NO REPORT OF INJURY OR DIRECT EXPOSURE TO THE LEAK. ERRONEOUS PATIENT 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
    510555 CYTOMICS FC 500 MPL FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1