BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS 2008T HEMODIALYSIS SYSTEM WITH CDK

    MDR report key: 4553109 · Received February 26, 2015

    Report

    Report Number
    2937457-2015-00277
    Event Type
    Death
    Date Received
    February 26, 2015
    Date of Event
    January 26, 2015
    Report Date
    January 28, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K113427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT. BASED ON THE INFO PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKER CLINICAL DEPT IS IN THE PROCESS OF REQUESTING ADD'L RELEVANT PT MEDICAL RECORDS AND TREATMENT DATA REGARDING THE REPORTED EVENT AND A PLANT INVESTIGATION IS UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE CLINICAL STAFF'S ASSESSMENT OF THE REPORTED INFO AND THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    THE USER FACILITY'S BIOMEDICAL TECH REPORTED THAT PT EXPIRED DURING HEMODIALYSIS TREATMENT. THE USER FACILITY REQUESTED A DEVICE EVAL. THE MFR'S REGIONAL EQUIPMENT SPECIALIST DETERMINED THE DEVICE WAS OPERATING TO SPECS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137175 FRESENIUS 2008T HEMODIALYSIS SYSTEM WITH CDK KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008T

    Patients

    Seq Age Sex Outcome Treatment
    1 Death NATURALYTE LIQUID BICARBONATE| COMBISET BLOODLINES,| OPTIFLUX DIALYZER,| NATURALYE,