BEUDAMED
    FDA Adverse Event Death Summary report: N

    2008K HEMODIALYSIS SYSTEM

    MDR report key: 3980401 · Received June 25, 2014

    Report

    Report Number
    2937457-2014-01598
    Event Type
    Death
    Date Received
    June 25, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 5, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    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. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW OF MEDICAL RECORDS BY POST MARKET CLINICAL PHYSICIAN AND COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DIALYSIS CLINIC THAT A PATIENT CODED DURING THE HEMODIALYSIS TREATMENT, EMD WAS CALLED BUT RESUSCITATION EFFORTS WERE NOT SUCCESSFUL, AND THE PATIENT EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370989 2008K HEMODIALYSIS SYSTEM KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death