BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FC500? FLOW CYTOMETER

    MDR report key: 3152514 · Received June 7, 2013

    Report

    Report Number
    1061932-2013-01101
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K030828
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER (BEC) FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE CHECKED THE PROBE POSITIONS IN RELATION TO THE SAMPLE HEAD AND NOTED THAT THE PROBE WAS TOO FAR UP AND DID NOT ALLOW VACUUM TO ASPIRATE SAMPLE. THE FSE ALSO NOTICED LOOSE PROBE NUT WHICH ALLOWED THE PROBE TO BECOME MIS-POSITIONED. THE FSE READJUSTED THE PROBE HEIGHT WHICH RESOLVED THE BACK-FLUSHING ISSUE. THE INSTRUMENT WAS OPERATIONAL. FAILURE MODE WAS MISS-POSITIONED PROBE CAUSING THE BACK-FLUSHING. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BECKMAN COULTER (BEC) THAT THE FC500 FLOW CYTOMETER WAS BACK-FLUSHING, CAUSING ISOFLOW TO DRIP INTO THE SAMPLE TUBES AND ONTO THE CAROUSEL. THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE INSTRUMENT DID NOT GENERATE ANY ERRORS IN CONNECTION WITH THIS EVENT. THE PROBLEM WAS DETECTED WHILE CUSTOMER WAS RUNNING QUALITY CONTROL (QC) AND NO PATIENT SAMPLES WERE RUN, THEREFORE NO ERRONEOUS RESULTS WERE GENERATED. NO DEATH, INJURY OR CHANGE TO PATIENT WAS ASSOCIATED WITH THIS EVENT. THE MATERIAL SAFETY DATA SHEET (MSDS) WAS REVIEWED BY THE CUSTOMER. THE CUSTOMER WAS WEARING GLOVES, A LABORATORY COAT AND GOGGLES. THERE WAS NO EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. THE OPERATOR DID NOT SEEK MEDICAL ATTENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252769 FC500? FLOW CYTOMETER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER FC500, 100-240V, 50/60HZ N/A

    Patients

    Seq Age Sex Outcome Treatment
    1