BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXSITE HD

    MDR report key: 3823112 · Received May 21, 2014

    Report

    Report Number
    3008110587-2014-00005
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    June 18, 2013
    Report Date
    May 21, 2014
    Manufacturer
    MARVAO MEDICAL
    Product Code
    MSD
    PMA / PMN Number
    K121933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE THE DEVICE HAS BEEN DISPOSED; THEREFORE, AN ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMS THAT THE LOT MET THE SPECIFICATION REQUIREMENTS. NO DEVIATIONS THAT COULD AFFECT PRODUCT QUALITY WERE FOUND. TAKING INTO CONSIDERATION THE EVALUATION CONDUCTED AND THE DETAILS OF THE COMPLAINT, THIS INVESTIGATION WAS ASSIGNED THE MOST PROBABLE ROOT CAUSE OF AN ANTICIPATED PROCEDURAL COMPLICATION. A COMPLAINT WITH A MOST PROBABLE ROOT CAUSE CLASSIFICATION OF AN ANTICIPATED PROCEDURAL COMPLICATION INDICATES THAT A DEVICE RELATED ROOT CAUSE DOES NOT APPLY AND THE COMPLAINT IS DUE TO A KNOWN EFFECT OF THE PROCEDURE. DEVICE DISPOSED BY USER.

    Description of Event or Problem · 1

    TR 0104 (RETROSPECTIVE EVALUATION): THE PATIENT HAD HER DEVICE IMPLANTED ON (B)(6) 2013. LOW FLOW RATES DEVELOPED AND THE DEVICE WAS REMOVED ON THIS DATE. THE EVENT RESOLVED AND THE PATIENT IS CURRENTLY DOING WELL USING AN ARTERIOVENOUS GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303735 NEXSITE HD NEXSITE HD MSD MARVAO MEDICAL 30764

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR