BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1061746 · Received June 13, 2008

    Report

    Report Number
    3003464075-2008-00256
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 18, 2008
    Report Date
    May 18, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR ENDING TREATMENT WITHOUT COMPLETING RINSEBACK. FACILITY STAFF ATTRIBUTED THE ALARMS TO AN OCCLUSION IN THE WASTE LINE AS A RESULT OF THE OPERATOR NOT PERFORMING THE REQUIRED FLUSHING PROCEDURE OF THE DRAIN LINE AS INSTRUCTED IN THE USER'S GUIDE. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE CYCLER ALARMED APPROPRIATELY. A DIRECT CORRELATION BETWEEN NXSTAGE SYS ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS PROVIDED ADD'L TRAINING REGARDING THE FLUSHING PROCEDURE. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADD'L INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AS AN ADVERSE EVENT SOLELY TO COMPLY WITH THE FDA'S BLOOD LOSS POLICY. MULTIPLE WASTE BAG PRESSURE ALARMS OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT WHICH COULD NOT BE RESOLVED BY THE OPERATOR. PARTIAL RINSEBACK WAS COMPLETED RESULTING IN AN ESTIMATED BLOOD LOSS OF 85CC. 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-170 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other