BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1030162 · Received April 16, 2008

    Report

    Report Number
    3003464075-2008-00169
    Event Type
    Injury
    Date Received
    April 16, 2008
    Date of Event
    March 18, 2008
    Report Date
    March 18, 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 RETURNED CARTRIDGE IS UNDER INVESTIGATION AT THE TIME OF THIS REPORT. THE REPORTED BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK AS INSTRUCTED IN THE USER'S GUIDE. THE USER'S GUIDE STATES TO CHECK THE WASTE FLUID FOR THE PRESENCE OF BLOOD, IF PINK TINGED TERMINATE TREATMENT AND RINSEBACK BLOOD. A BLOOD LOSS SHOULD NOT OCCUR IF DEVICE LABELING IS FOLLOWED. FACILITY STAFF HAS BEEN NOTIFIED. THERE HAVE BEEN NO SIMILAR PROBLEMS REPORTED SUBSEQUENT TO THIS EVENT. 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. A BLOOD LEAK DETECTOR ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR NOTED THE EFFLUENT WAS PINK. TREATMENT WAS DISCONTINUED 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 8017701

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other