BEUDAMED
    FDA Adverse Event Other Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 608221 · Received May 27, 2005

    Report

    Report Number
    3003464075-2005-00017
    Event Type
    Other
    Date Received
    May 27, 2005
    Date of Event
    May 1, 2005
    Report Date
    May 1, 2005
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE HEMODIALYSIS TREATMENT, A PATIENT BLOOD LOSS OF APPROXIMATELY 210CC OCCURRED. VENOUS AIR ALARMS OCCURRED DURING THE TREATMENT AND NXSTAGE PERSONNEL WERE ONCTACTED VIA TELEPHONE TO ASSIST WITH TROUBLESHOOTING . BEFORE THE ALARMS COULD BE RESOLVED, IT WAS DETERMINED THAT TOO MUCH TIME HAD ELAPSED AND THERE WAS CONCERN REGARDING POTENTIAL CLOTTING OF THE CIRCUIT. AS A RESULT, THE BLOOD CIRCUIT WAS DISCARDED WITHOUT RETURNING THE PATIENT'S BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM KDI NXSTAGE MEDICAL, INC. CAR-156 FG-050225-01

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other