BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1615774 · Received February 17, 2010

    Report

    Report Number
    3003464075-2010-00017
    Event Type
    Malfunction
    Date Received
    February 17, 2010
    Date of Event
    January 19, 2010
    Report Date
    January 19, 2010
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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

    PATIENT IDENTIFIERS WERE NOT PROVIDED BY THE REPORTER. THE NURSE OBSERVED A SMALL BLOOD LEAK, LESS THAN 20CC, AT THE BOTTOM OF THE FILTER DURING TWO EXTENDED CRRT TREATMENTS. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC FOR EACH. 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 9097803

    Patients

    Seq Age Sex Outcome Treatment
    1