BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1289094 · Received January 14, 2009

    Report

    Report Number
    3003464075-2009-00020
    Event Type
    Injury
    Date Received
    January 14, 2009
    Date of Event
    December 17, 2008
    Report Date
    December 17, 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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE REPORTED BLOOD LOSS IS ATTRIBUTED TO CLOTTING OF THE EXTRACORPOREAL BLOOD CIRCUIT, PREVENTING RINSEBACK OF THE PT'S BLOOD. THE VENOUS PRESSURE HIGH ALARM WAS ATTRIBUTED TO A CLOTTED VENOUS LINE, INDICATING THAT THE CYCLER ALARMED APPROPRIATELY. 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 INFORMATION 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. A VENOUS PRESSURE HIGH ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. CLOTTING OF THE VENOUS LINE WAS OBSERVED. PARTIAL RINSEBACK WAS PERFORMED RESULTING IN AN ESTIMATED BLOOD LOSS OF 140CC. 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 808775

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other