BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1013359 · Received March 13, 2008

    Report

    Report Number
    3003464075-2008-00109
    Event Type
    Injury
    Date Received
    March 13, 2008
    Date of Event
    February 14, 2008
    Report Date
    February 15, 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. THE USER'S GUIDE INSTRUCTS THE OPERATOR TO PROMPTLY RINSEBACK THE PT'S BLOOD IN THE EVENT OF AN UNRECOVERABLE ALARM. NO PROBLEM WAS FOUND WITH THE RETURNED ANCILLARY PROD. THE REPORTED ALARMS WERE MOST LIKELY CAUSED BY A LOOSE CONNECTION MADE BY THE OPERATOR. A DIRECT CORRELATION BETWEEN NXSTAGE SYS ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS 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. AN ALARM OCCURRED FROM THE DIALYSATE DELIVERY SYS DURING A ROUTINE HEMODIALYSIS TREATMENT. RINSEBACK WAS ATTEMPTED BUT NOT COMPLETED DUE TO CLOTTING OF THE EXTRACORPOREAL CIRCUIT, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. 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 41 YR Other