BEUDAMED
    FDA Adverse Event Death Summary report: N

    FRESENIUS DIALYSIS DELIVERY SYSTEM

    MDR report key: 3250198 · Received July 23, 2013

    Report

    Report Number
    2937457-2013-00099
    Event Type
    Death
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 26, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEMODIALYSIS MACHINE (PLANT INVESTIGATION) IS CURRENTLY UNDERGOING EVALUATION. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET CLINICAL DEPARTMENT IS IN THE PROCESS OF REQUESTING PATIENT MEDICAL RECORDS AND TREATMENT DATA INFORMATION REGARDING THE REPORTED PATIENT ADVERSE EVENT DURING THE HEMODIALYSIS TREATMENT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ONCE THE PLANT INVESTIGATION AND CLINICAL INVESTIGATIONS ARE COMPLETE. THIS IS ONE OF 4 MDR'S SUBMITTED TO DOCUMENT THIS REPORTED EVENT. PLEASE REFERENCE THE FOLLOWING MDR NUMBERS: 8030665-2013-00470; 1713747-2013-00275; 3005162618-2013-00015.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE USER FACILITY BIOMED TECH THAT A HEMODIALYSIS PATIENT HAD EXPIRED DURING THEIR DIALYSIS TREATMENT. A REQUEST FOR ADDITIONAL PATIENT EVENT AND MEDICAL RECORDS HAS BEEN MADE. THIS MDR INCLUDES ALL INFORMATION PROVIDED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342757 FRESENIUS DIALYSIS DELIVERY SYSTEM KDI FRESENIUS MEDICAL CARE NORTH AMERICA 2008K

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R ACID CONCENTRATE| FRESENIUS COMBISET ACCESS FLOW BLOODLINES| DIALYZER