BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1212723 · Received October 21, 2008

    Report

    Report Number
    3003464075-2008-00505
    Event Type
    Malfunction
    Date Received
    October 21, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 22, 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 CYCLER ALARMED APPROPRIATELY TO THE AIR IN THE CIRCUIT. THE USER'S GUIDE CONTAINS ADEQUATE INFO REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. AIR ALARMS DURING RINSEBACK ARE USUALLY CAUSED BY AIR INTRODUCED WHEN MAKING PT CONNECTIONS FOR RINSEBACK. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAVE BEEN NOTIFIED. 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. AN ARTERIAL AIR ALARM OCCURRED DURING RINSEBACK OF A ROUTINE HEMODIALYSIS TREATMENT, WHICH COULD NOT BE RESOLVED BY THE OPERATOR. VISIBLE AIR WAS SEEN IN THE CIRCUIT. PARTIAL RINSEBACK WAS COMPLETED, RESULTING IN AN ESTIMATED BLOOD LOSS OF 50CC. 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 44 YR Other