BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 6406966 · Received March 15, 2017

    Report

    Report Number
    3003464075-2017-00014
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    February 19, 2017
    Report Date
    March 15, 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 DEVICE WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE PRIOR SERVICE WORK HISTORY SHOWED THAT THE DEVICE MET ALL STANDARD ACCEPTANCE TESTING CRITERIA PERFORMED BY A QUALIFIED SERVICE TECHNICIAN. DETAILS REGARDING THE ELECTRICAL CONNECTIONS AND POWER SOURCE IN THE PATIENT¿S RV AND IN USE AT THE TIME OF THE EVENT COULD NOT BE CONFIRMED. NO ADDITIONAL INFORMATION REGARDING THE POSSIBLE LEAK WAS PROVIDED. 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 FEBRUARY 19, 2017 FROM A (B)(6) MALE PATIENT THAT THE EXPRESS FLUID WARMER (EFW) CAUGHT FIRE IN HIS RECREATIONAL VEHICLE (RV). THE EFW WAS REMOVED FROM USE AND THE PATIENT STATED THAT HE CONTINUED TREATING UNTIL HE FELT TOO COLD TO CONTINUE. TREATMENT WAS COMPLETED 15 MINUTES EARLIER THAN EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187999 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. FW-300

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other