BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYTOMICS FC500 FLOW CYTOMETER SYSTEM

    MDR report key: 3885235 · Received June 19, 2014

    Report

    Report Number
    1061932-2014-01403
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 28, 2014
    Report Date
    May 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K030828
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2014, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE INSTRUMENT AND FOUND THAT THE POSITION OF THE SAMPLE HEAD HAD SLIPPED DOWN BEYOND THE POSITION WHERE THE VACUUM APPLIED DURING THE CLEANING CYCLE COULD CAPTURE THE SHEATH FLUID AND REMOVE IT TO WASTE. THIS RESULTED IN THE LEAK. THE FSE RAISED AND REPOSITIONED THE SAMPLE HEAD BACK TO THE CORRECT HEIGHT AND LOCKED DOWN THE SAMPLE HEAD. THIS ACTION RESOLVED THE PROBLEM AND MADE THE INSTRUMENT OPERATIONAL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK WHEN USING THE CYTOMICS FC500 FLOW CYTOMETER SYSTEM. THE LEAK WAS FLUID BACKFLUSHING INTO THE SAMPLE TUBE AND HAD LEAKED ONTO THE CAROUSEL AND CAROUSEL BASE OF THE INSTRUMENT. THE VOLUME OF THE LEAK WAS ABOUT 1ML AND WAS CONTAINED WITHIN THE INSTRUMENT. THE OPERATOR WAS WEARING LAB COAT, GOGGLES, AND GLOVES AT THE TIME OF THE INCIDENT. THERE WAS NO REPORT OF BIOHAZARD EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS. A BECKMAN COULTER FIELD SERVICE ENGINEER WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE INSTRUMENT. THERE WAS NO REPORT OF ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361518 CYTOMICS FC500 FLOW CYTOMETER SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1