BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1365378 · Received February 3, 2009

    Report

    Report Number
    3003464075-2009-00045
    Event Type
    Malfunction
    Date Received
    February 3, 2009
    Date of Event
    January 4, 2009
    Report Date
    January 5, 2009
    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 NOT PERFORMING RINSEBACK AS INSTRUCTED IN THE USER'S GUIDE. THE REPORTED ALARMS ARE INDICATIVE OF LACK OF DIALYSATE FLOW TO THE CYCLER AND DO NOT SUGGEST A MALFUNCTION OCCURRED. OCCASIONAL ALARMS DURING DIALYSIS ARE EXPECTED AND SHOULD NOT RESULT IN A BLOOD LOSS IF DEVICE LABELING IS FOLLOWED. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL 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. HIGH WASTE BAG PRESSURE ALARMS OCCURRED AT THE BEGINNING OF TWO CONSECUTIVE ROUTINE HEMODIALYSIS TREATMENTS WHICH COULD NOT BE RECOVERED BY THE OPERATOR. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 50CC FOR EACH TREATMENT. 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 8097709

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other