BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® ACT DIFF[ ANALYZER

    MDR report key: 3780948 · Received April 30, 2014

    Report

    Report Number
    1061932-2014-00946
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K973634
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED. THE FSE FOUND THE PINCH VALVE LV14 AND LV15 WERE DEFECTIVE. PINCH VALVES LV14 AND LV15 CONTROL THE DRAIN FOR THE BATHS. THE FSE REPLACED THE PINCH VALVES AND THE RESPECTIVE TUBING AND THE INSTRUMENT RAN WITHOUT ANY LEAKS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LEAK FROM UNDER THE BATHS OF THE ACT DIFF INSTRUMENT. THE CUSTOMER WAS IN THE MIDDLE OF RUNNING CONTROLS WHEN THE LEAK WAS NOTICED. THE VOLUME OF THE LEAK WAS NOT SPECIFIED AND WAS NOT CONTAINED WITHIN THE INSTRUMENT. THERE WAS NO BIOHAZARD EXPOSURE TO OPEN WOUNDS OR MUCOUS MEMBRANES. NO ERRONEOUS PATIENT RESULTS WERE GENERATED IN CONNECTION WITH THIS EVENT..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259657 COULTER® ACT DIFF[ ANALYZER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability