BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE/SYSTEM ONE

    MDR report key: 2132261 · Received November 13, 2008

    Report

    Report Number
    2132261
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 10, 2008
    Manufacturer
    NXSTAGE MEDICAL INC.
    Product Code
    KDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    NXSTAGE IS A MFR OF HEMODIALYSIS EQUIPMENT AND CARTRIDGES FOR DIALYSIS. PT EXPERIENCES 3 SEPARATE LEAKS ONE BEFORE DIALYSIS TREATMENT AND TWO WHILE SHE WAS DIALYZING. HER DIALYSIS TREATMENT WAS TERMINATED AND THE BLOOD RETURNED TO PT. PT DIALYZES AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE/SYSTEM ONE DIALYSIS MACHINE KDI NXSTAGE MEDICAL INC. 8077712

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR