BEUDAMED
    FDA Adverse Event Other Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 609639 · Received June 1, 2005

    Report

    Report Number
    3003464075-2005-00018
    Event Type
    Other
    Date Received
    June 1, 2005
    Date of Event
    May 2, 2005
    Report Date
    May 3, 2005
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE HEMODIALYSIS TREATMENT, A PT BLOOD LOSS OF APPROXIMATELY 210 CC OCCURRED. THIS EVENT WAS NOT ASSOCIATED WITH A DEVICE MALFUNCTION OR SERIOUS INJURY AND IS BEING REPORTED SOLELY TO COMPLY WITH THE FDA'S BLOOD LOSS POLICY. IT WAS REPORTED THAT ARTERIAL ACCESS NEEDLE PROBLEMS OCCURRED SHORTLY AFTER THE TREATMENT STARTED. THE BLOOD CIRCUIT CLOTTED WHILE ATTENDING TO THE ARTERIAL ACCESS AND HAD TO BE DISCARDED. 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-050325-01

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other