BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 6807815 · Received August 21, 2017

    Report

    Report Number
    3003464075-2017-00037
    Event Type
    Malfunction
    Date Received
    August 21, 2017
    Date of Event
    July 25, 2017
    Report Date
    August 21, 2017
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K071263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARMER WAS RECEIVED FOR EVALUATION AND FOUND NO MELTING ON THE EXTERIOR SURFACE. SOME BLACK SOOT-LIKE MATERIAL WAS NOTED AND THE POWER CORD WAS MELTED TO THE AC INLET. NO OTHER COMPONENT WAS VISIBLY DAMAGED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND SHOWS THE UNIT WAS RELEASED FOR DISTRIBUTION HAVING MET ALL PRODUCT DESIGN REQUIREMENTS. THE EXPRESS FLUID WARMER MEETS REQUIREMENTS FOR ELECTRICAL AND SAFETY STANDARDS AS OUTLINED IN THE USER GUIDE. THE USER GUIDE WARNS THAT THE EXPRESS FLUID WARMER MUST BE PLUGGED INTO THE AC POWER ACCESSORY OUTLET ON THE BACK OF THE NXSTAGE SYSTEM ONE CYCLER AND THAT THE POWER INTERCONNECT CORD MUST BE INSPECTED BEFORE EACH USE. IT STATES THAT PROPER ELECTRICAL HOOKUP IN FULL COMPLIANCE WITH ALL APPLICABLE CODES AND DEVICE SPECIFICATIONS MUST BE MAINTAINED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON (B)(6) 2017 REGARDING PATIENT HH, A (B)(6) YEAR OLD FEMALE. THE REPORT STATES THAT THE EXPRESS FLUID WARMER (EFW) SPARKED, SMOKED AND CAUGHT FIRE. THE PATIENT WAS NOT CONNECTED TO THE DEVICE AT THE TIME OF THE EVENT. DAMAGE WAS CONFINED TO THE EFW AND THERE WAS NO DAMAGE TO THE PATIENT'S HOME. THERE WERE NO INJURIES RELATED TO THE EVENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586816 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. FW-300

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Other