BEUDAMED
    FDA Adverse Event Other Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 614661 · Received June 17, 2005

    Report

    Report Number
    3003464075-2005-00021
    Event Type
    Other
    Date Received
    June 17, 2005
    Date of Event
    May 14, 2005
    Report Date
    May 20, 2005
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE HEMODIALYSIS TREATMENT, A VENOUS PRESSURE LOW ALARM OCCURRED. IT WAS DETERMINED THAT THE EXTRACORPOREAL BLOOD CIRCUIT WAS CLOTTED PRECLUDING MANUAL RINSBACK OF THE PT'S BLOOD. THE CIRCUIT WAS DISCARDED RESULTING IN A BLOOD LOSS OF APPROXIMATELY 225 CC. NO MEDICAL INTERVENTION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-153 FG-050331-01

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other