BEUDAMED
    FDA Adverse Event Other Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 592841 · Received April 20, 2005

    Report

    Report Number
    3003464075-2005-00011
    Event Type
    Other
    Date Received
    April 20, 2005
    Date of Event
    March 21, 2005
    Report Date
    March 21, 2005
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE HEMODIALYSIS TREATMENT, A PT BLOOD LOSS OF APPROXIMATELY 210CC OCCURRED. IT WAS REPORTED THAT THE CYCLER HAD ARTERIAL AIR ALARMS THAT COULD NOT BE RESOLVED. A MANUAL RINSEBACK OF THE PT'S BLOOD COULD NOT BE PERFORMED AS THE EXTRACORPOREAL BLOOD CIRCUIT WAS CLOTTED. THE CIRCUIT WAS DISCARDED RESULTING IN THE REPORTED PT BLOOD LOSS. NO MEDICAL INTERVETION 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-156 FG-C50127-02

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other