BEUDAMED
    FDA Adverse Event Other Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 606465 · Received May 25, 2005

    Report

    Report Number
    3003464075-2005-00014
    Event Type
    Other
    Date Received
    May 25, 2005
    Date of Event
    April 25, 2005
    Report Date
    April 25, 2005
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING A ROUTINE HEMODIALYSIS TREATMENT A PT BLOOD LOSS OF APPROXIMATELY 200 CC OCCURRED. THIS EVENT WAS NOT ASSOCIATED WITH A DEVICE MALFUNCTION OR SERIOUS INJURY AND IS BEING REPORTED SOLELY TO COMPLY WITH THE FDA'S BLOOD LOSS POLICY. IT WAS REPORTED THE MULTIPLE VENOUS AIR ALARMS OCCURRED AT THE START OF THE TREATMENT. MANUAL AIR REMOVAL WAS ATTEMPTED BUT TOO MUCH AIR WAS IN THE BLOOD CIRCUIT TO ALLOW RECOVERY. THE BLOOD CIRCUIT WAS DISCARDED RESULTING IN THE PT BLOOD LOSS. 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-156 FG-050304-01

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other