BEUDAMED
    FDA Adverse Event Summary report: N

    NXSTAGE MACHINE

    MDR report key: 3212696 · Received July 1, 2013

    Report

    Report Number
    MW5030781
    Date Received
    July 1, 2013
    Date of Event
    April 2, 2013
    Report Date
    June 20, 2013
    Manufacturer
    NXSTAGE MEDICAL
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    NXSTAGE MACHINE # 769138 ALARMED, SCREEN WENT YELLOW, ERROR CODE 141. CLINICAL ENGINEERING AND NXSTAGE CONTACTED. NXSTAGE ADVISED STAFF TO TURN OFF AND RESTART MACHINE, THAT IT WAS DOOR ALARM. STAFF WERE AT DESK WHEN THIS ALARM OCCURRED. NO ONE WAS IN ROOM TO BUMP DOOR. POWER WAS LOST FOR GREATER THAN 2 MINUTES, THUS BLOOD IN CIRCUIT COULD NOT BE RETURNED. MACHINE CAME BACK UP BUT NOT DISPLAY SCREEN. CLINICAL ENGINEERING WAS ABLE TO GET DISPLAY SCREEN BACK UP. BIOMED ABLE TO GET SCREEN BACK UP IN WORKING ORDER. PT REQUIRE 1 UNIT PRBC'S SECONDARY TO BLOOD LOST IN CIRCUIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297300 NXSTAGE MACHINE NONE KDI NXSTAGE MEDICAL 769138

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention