BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 1933332 · Received December 14, 2010

    Report

    Report Number
    3003464075-2010-00135
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    KDI
    PMA / PMN Number
    K050525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DISPOSABLE CARTRIDGE WAS DISCARDED AND AVAILABLE FOR EVAL. THE REPORTED EVENT CANNOT BE CONFIRMED. A REVIEW OF THE REPORTED CARTRIDGE LOT NUMBER FOUND NO OTHER SIMILAR COMPLAINTS REPORTED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFO WILL BE PROVIDED.

    Description of Event or Problem · 1

    AT THE START OF A ROUTINE HEMODIALYSIS TREATMENT BLOOD WAS OBSERVED LEAKING FROM THE TUBING JUNCTION AT THE HEADER OF THE DIALYZER. TREATMENT WAS DISCONTINUED WITHOUT PERFORMING RINSEBACK, RESULTING IN AN ESTIMATED BLOOD LOSS OF 250CC. 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-170-B 0067703

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR