BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1639733 · Received March 17, 2010

    Report

    Report Number
    3003464075-2010-00027
    Event Type
    Malfunction
    Date Received
    March 17, 2010
    Date of Event
    February 13, 2010
    Report Date
    February 17, 2010
    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

    THE CARTRIDGE WAS DISPOSED OFF AND IS NOT AVAILABLE FOR EVALUATION. THEREFORE THE REPORTED EVENT CANNOT BE CONFIRMED. REVIEW OF DEVICE HISTORY RECORDS FOR THIS LOT OF CARTRIDGES 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 A CRRT TREATMENT. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 190CC. THE EXACT AMOUNT OF BLOOD LOSS FROM THE LEAK WAS NOT KNOWN, BUT IS ESTIMATED TO BE MINIMAL TO MODERATE. NO SERIOUS INJURY OR 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 42 YR Other