BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1882572 · Received October 22, 2010

    Report

    Report Number
    3003464075-2010-00103
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 25, 2010
    Report Date
    September 25, 2010
    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 OF THE PATIENT'S BLOOD FOLLOWING AN UNRECOVERABLE ALARM. THE USER'S GUIDE STATES TO TERMINATE TREATMENT AND RINSEBACK THE PATIENT'S BLOOD IN THE EVENT THAT AN ALARM CANNOT BE RESOLVED PROMPTLY. OCCASIONAL ALARMS DURING DIALYSIS 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 ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    AN ALARM OCCURRED FROM THE DIALYSATE DELIVERY SYSTEM DURING A ROUTINE HEMODIALYSIS TREATMENT. THE OPERATOR DISCONTINUED THE DIALYSIS TREATMENT WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PATIENT'S STANDARD ARANESP DOSE WAS INCREASED. NO OTHER 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-B 0077711

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other