BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1150498 · Received September 4, 2008

    Report

    Report Number
    3003464075-2008-00412
    Event Type
    Injury
    Date Received
    September 4, 2008
    Date of Event
    August 9, 2008
    Report Date
    August 9, 2008
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE PATIENT'S NEEDLE DISLODGING DURING TREATMENT, AND NOT PERFORMING RINSEBACK OF THE PATIENT'S BLOOD. THE USER'S GUIDE STATES THAT THE NXSTAGE CYCLER MAY NOT SENSE SLOW FLUID OR BLOOD LEAKS RESULTING FROM LOOSE CONNECTIONS, FAULTY COMPONENTS, VENOUS ACCESS DISCONNECTION OR OTHER POTENTIAL CAUSES. LEAKING FLUIDS COULD LEAD TO BLOOD LOSS, INJURY, OR DEATH. LEAKING FLUIDS COULD ALSO CAUSE A PERSON TO SLIP OR FALL. ALWAYS TIGHTEN AND RECHECK PATIENT VASCULAR ACCESS AND ALL FLUID LINES, CONNECTIONS, CAPS AND CLAMPS. SECURE THE BLOOD ACCESS DEVICE TO THE PATIENT. VISUALLY INSPECT THE SYSTEM PERIODICALLY FOR EVIDENCE OF LEAKS. TERMINATE TREATMENT IF LEAK CANNOT BE RESOLVED. 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. THE PATIENT'S NEEDLE DISLODGED DURING A ROUTINE HEMODIALYSIS TREATMENT. TREATMENT WAS DISCONTINUED WITHOUT RINSEBACK, RESULTING IN A BLOOD LOSS OF 190CC. THE ADDITIONAL BLOOD LOSS AMOUNT FROM THE NEEDLE DISLODGEMENT WAS NOT KNOWN BUT DESCRIBED AS "NOT VERY MUCH". NO MEDICAL INTERVENTION WAS REQUIRED SPECIFICALLY TO ADDRESS THE BLOOD LOSS.

    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 64 YR Other