BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE PUREMA

    MDR report key: 1622349 · Received February 23, 2010

    Report

    Report Number
    1622349
    Event Type
    Malfunction
    Date Received
    February 23, 2010
    Date of Event
    February 13, 2010
    Report Date
    February 22, 2010
    Manufacturer
    NXSTAGE MEDICAL INC.
    Product Code
    FJK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RECEIVING NEXT STAGE DIALYSIS, MACHINE WAS INTERMITTENTLY ALARMING (WOULD ALARM THEN STOP ON ITS ON). I ENTERED THE ROOM TO CHECK ON MY PT, AND FOUND BLOOD SPRAYING ONTO THE WALL FROM THE BACK OF THE NEXT STAGE MACHINE (FILTER).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE PUREMA NXSTAGE DIALYSIS TUBING FJK NXSTAGE MEDICAL INC. CAR 500 9097803

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR