BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 7397711 · Received April 4, 2018

    Report

    Report Number
    3003464075-2018-00017
    Event Type
    Malfunction
    Date Received
    April 4, 2018
    Date of Event
    March 8, 2018
    Report Date
    April 4, 2018
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K071263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARMER WAS RECEIVED FOR EVALUATION AND A BURNT AC CONNECTOR WAS CONFIRMED. TRACES OF SALINE WERE FOUND IN THE CONNECTOR, AND THE FINDINGS WERE CONSISTENT WITH AN ELECTRICAL SHORT CAUSED BY THE PRESENCE OF SALINE. THE POWER CORD WAS NOT RETURNED FOR EVALUATION AND DETAILS OF THE ELECTRICAL CONNECTIONS AT THE PATIENT'S HOME COULD NOT BE CONFIRMED. 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. UDI: (B)(4). NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM A HOME THERAPY NURSE ON (B)(6) 2018 REGARDING AN EXPRESS FLUID WARMER (EFW) THAT CAUGHT FIRE AND MELTED THE POWER CORD. THE PATIENT, A (B)(6) YEAR OLD FEMALE, WAS NOT CONNECTED TO THE DEVICE AT THE TIME OF THE EVENT. DAMAGE WAS CONFINED TO THE EFW WHICH WAS REMOVED FROM USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241108 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. FW-300

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other