BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1354996 · Received March 31, 2009

    Report

    Report Number
    3003464075-2009-00147
    Event Type
    Injury
    Date Received
    March 31, 2009
    Date of Event
    March 2, 2009
    Report Date
    March 2, 2009
    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 REPORTED BLOOD LOSS IS ATTRIBUTED TO USER ERROR AS THE OPERATOR INADVERTENTLY INTRODUCED AIR INTO THE CIRCUIT DURING TREATMENT. THE CYCLER ALARMED APPROPRIATELY. THE USER'S GUIDE PROVIDES ADEQUATE INSTRUCTIONS FOR PERFORMING AIR REMOVAL. A DIRECT CORRELATION BETWEEN NXSTAGE SYSTEM ONE AND THE REPORTED BLOOD LOSS CANNOT BE ESTABLISHED. 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. DURING A ROUTINE HEMODIALYSIS TREATMENT, THE OPERATOR INADVERTENTLY INTRODUCED AIR INTO THE CIRCUIT WHILE ADMINISTERING MEDICATION WITH A SYRINGE VIA THE POST FILTER PORT, WHICH CAUSED A VENOUS AIR ALARM TO OCCUR. THE OPERATOR INADVERTENTLY INTRODUCED AIR INTO THE CIRCUIT WHILE ADMINISTERING MEDICATION WITH A SYRINGE VIA THE POST FILTER PORT, WHICH CAUSED A VENOUS AIR ALARM TO OCCUR. THE OPERATOR WAS UNABLE TO RESOLVE THE ALARM AND DISCONTINUED 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 8067703

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other