BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1614819 · Received February 12, 2010

    Report

    Report Number
    3003464075-2010-00015
    Event Type
    Malfunction
    Date Received
    February 12, 2010
    Date of Event
    January 18, 2010
    Report Date
    January 18, 2010
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    PT IDENTIFIERS WERE NOT PROVIDED BY THE REPORTER. THE NURSE OBSERVED A BLOOD LEAK AT THE BOTTOM OF THE FILTER DURING AN EXTENDED CRRT TREATMENT. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. NO MEDICAL INTERVENTION WAS REPORTED.

    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 9106807

    Patients

    Seq Age Sex Outcome Treatment
    1