BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1061654 · Received June 17, 2008

    Report

    Report Number
    3003464075-2008-00262
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 21, 2008
    Report Date
    May 21, 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 REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK AS INSTRUCTED. THE USER'S GUIDE STATES TO POWER CYCLE THE SYS AND PERFORM RINSEBACK IF THE ALARM RECURS. THE CYCLER CONTINUES TO BE USED FOR TREATMENTS WITHOUT FURTHER PROBLEMS. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. 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. A SYS ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR ENDED TREATMENT WITHOUT PERFORMING RINSEBACK, 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 8017710

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other