BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1593354 · Received January 25, 2010

    Report

    Report Number
    3003464075-2010-00012
    Event Type
    Malfunction
    Date Received
    January 25, 2010
    Date of Event
    December 30, 2009
    Report Date
    December 30, 2009
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE RETURNED CARTRIDGE CONFIRMED A CRACK OCCURRED IN THE ARTERIAL CAP ON THE FILTER. REVIEW OF DEVICE HISTORY RECORDS REVEALED THE LOT OF CAP COMPONENTS MET ALL SPECIFICATION REQUIREMENTS. MECHANICAL INTEGRITY TESTING OF RETAINED SAMPLES MET ALL ACCEPTANCE CRITERIA. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    BLOOD WAS OBSERVED LEAKING FROM THE FILTER DURING AN EXTENDED CVVHD TREATMENT RESULTING IN AN APPROXIMATE BLOOD LOSS OF 50CC. THE REPORTER INDICATED THERE HAD BEEN TWO PREVIOUS CARTRIDGES CHANGED DUE TO CLOTTING AND HIGH PRESSURE ALARMS WHICH WERE OVERRIDDEN DURING THIS TREATMENT. 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-500 9097803

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR