BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1882497 · Received October 20, 2010

    Report

    Report Number
    3003464075-2010-00102
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 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

    THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. THE BLOOD LOSS IS ATTRIBUTED TO THE OPERATOR NOT PERFORMING RINSEBACK IN A TIMELY MANNER. THE USER'S GUIDE CONTAINS ADEQUATE INFORMATION REGARDING PROBABLE CAUSES OF ALARMS AND ALARM RECOVERY INSTRUCTIONS. NO FURTHER SIMILAR ALARMS HAVE BEEN REPORTED. THE PATIENT'S STANDARD EPOGEN DOSE WAS INCREASED IN PART DUE TO THE BLOOD LOSS AND DUE TO AN ABSCESS THAT WAS NOT MEDICALLY TREATED. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A SYSTEM ALARM OCCURRED DURING A ROUTINE HEMODIALYSIS TREATMENT WHICH COULD NOT BE RESOLVED. THE OPERATOR COULD NOT COMPLETE RINSEBACK DUE TO POSSIBLE CLOTTING, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE PATIENT'S STANDARD EPOGEN DOSE WAS INCREASED IN PART DUE TO THE BLOOD LOSS EVENT AND ALSO DUE TO AN ABSCESS THAT HAD NOT BEEN MEDICALLY TREATED. 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 0067708

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other