BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1251756 · Received December 3, 2008

    Report

    Report Number
    3003464075-2008-00628
    Event Type
    Injury
    Date Received
    December 3, 2008
    Date of Event
    November 6, 2008
    Report Date
    November 6, 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. THE USER'S GUIDE INSTRUCTS THE OPERATOR TO PROMPTLY RINSEBACK THE PT'S BLOOD IN THE EVENT OF AN UNRECOVERABLE ALARM. EVAL OF THE RETURNED CYCLER DETERMINED THAT THE ALARM WAS CAUSED BY A LOOSE COMPONENT. THE CYCLER ALARMED APPROPRIATELY. THIS APPEARS TO BE A RANDOM ISOLATED EVENT. THERE HAVE BEEN NO OTHER SIMILAR PROBLEMS IDENTIFIED. OCCASIONAL ALARMS DURING HEMODIALYSIS TREATMENT ARE EXPECTED AND SHOULD NOT RESULT IN A BLOOD LOSS IF DEVICE LABELING IS FOLLOWED. FACILITY STAFF HAS BEEN NOTIFIED. 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. BALANCE CHAMBER PRESSURE ALARMS OCCURRED SHORTLY AFTER THE START OF A ROUTINE HEMODIALYSIS TREATMENT, WHICH COULD NOT BE RESOLVED BY THE OPERATOR. RINSEBACK WAS NOT PERFORMED PER FACILITY PROTOCOL, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190 CC. 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 8067703

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other