BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® LH 750 HEMATOLOGY ANALYZER

    MDR report key: 3160758 · Received June 10, 2013

    Report

    Report Number
    1061932-2013-01051
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K011342
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED AND NOTICED A SCRATCHED BSV (BLOOD SAMPLING VALVE) PAD. THE FSE REPLACED THE BSV PAD TO RESOLVE THE LEAK AND VERIFIED REPAIRS PER ESTABLISHED PROCEDURES. FAILURE MODE OF THE LEAK IS ATTRIBUTED TO A SCRATCHED BSV PAD. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NOTICING FLUID UNDERNEATH THE BSV (BLOOD SAMPLING VALVE) IN THE DRIP TRAY WHILE CLEANING THE COULTER LH 750 HEMATOLOGY ANALYZER. THE CUSTOMER TOOK APART THE BSV TO CLEAN THE INSTRUMENT AND NOTICED THAT ONE OF THE PIECES OF THE BSV CERAMIC PAD APPEARED CRACKED. THE CUSTOMER PUT THE BSV BACK TOGETHER, INITIATED A CYCLE, AND OBSERVED A FEW DROPS OF FLUID DRIPPING FROM THE BSV ONTO THE DRIP TRAY. THE CUSTOMER INDICATED THAT THE LEAK WAS CONTAINED WITHIN THE INSTRUMENT. THE CUSTOMER WAS WEARING GLOVES AT THE TIME OF THE EVENT AND NO INJURY OR EXPOSURE WAS REPORTED. NO ERRONEOUS RESULTS WERE GENERATED AND THERE WAS NO CHANGE OR AFFECT TO PATIENT TREATMENT IN CONNECTION WITH THIS EVENT. THE CUSTOMER STOPPED USING THE INSTRUMENT UNTIL IT COULD BE SERVICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260435 COULTER® LH 750 HEMATOLOGY ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1