BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NXSTAGE SYSTEM ONE

    MDR report key: 7288390 · Received February 22, 2018

    Report

    Report Number
    3003464075-2018-00008
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    February 1, 2018
    Report Date
    February 22, 2018
    Manufacturer
    NXSTAGE MEDICAL, INC.
    Product Code
    FKR
    PMA / PMN Number
    K140571
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETAINED FOR INVESTIGATION. THE USER GUIDE PROVIDES INSTRUCTION TO MAINTAIN ASEPTIC TECHNIQUE AND WARNINGS TO FOLLOW INSTRUCTIONS PROVIDED TO PREVENT THE RISK OF EXPOSURE TO INFECTIOUS DISEASES. A LOT NUMBER WAS NOT IDENTIFIED. ALL AVAILABLE INFORMATION SUPPORTS THAT THE PRODUCT WAS FUNCTIONING AS DESIGNED AND THERE WAS NO MALFUNCTION. BIOCOMPATIBILITY OF THE DEVICE HAS BEEN ESTABLISHED. NXSTAGE MEDICAL CONSIDERS THIS REPORT CLOSED. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED ON 1 FEB 2018 FROM THE CAREGIVER OF A (B)(6) MALE WHO WAS NOT FEELING WELL. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2017. THOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134525 NXSTAGE SYSTEM ONE HIGH PERMEABILITY HEMODIALYSIS SYSTEM FKR NXSTAGE MEDICAL, INC. SAK-304

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization