BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1001088 · Received February 22, 2008

    Report

    Report Number
    3003464075-2008-00078
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 26, 2008
    Report Date
    January 26, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    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 IN A TIMELY MANNER FOLLOWING AN UNRECOVERABLE ALARM. THE USER'S GUIDE INSTRUCTS THE OPERATOR TO PROMPTLY RINSEBACK THE PT'S BLOOD IN THE EVENT OF AN UNRECOVERABLE ALARM. REVIEW OF THE TREATMENT LOG FILES INDICATES THAT THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. FACILITY STAFF HAS BEEN NOTIFIED OF THE EVENT. 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. DURING A ROUTINE HEMODIALYSIS TREATMENT, MULTIPLE HIGH WASTE BAG PRESSURE ALARMS OCCURRED WHICH COULD NOT BE RESOLVED. MANUAL RINSEBACK WAS ATTEMPTED, BUT NOT COMPLETED DUE TO CLOTTING, RESULTING IN AN ESTIMATED BLOOD LOSS OF 100CC. THE PT'S ROUTINE EPOGEN DOSE WAS INCREASED. NO FURTHER 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 65 YR Other