BEUDAMED
    FDA Adverse Event Death Summary report: N

    TWITTER REVERSE FLOW DEVICE

    MDR report key: 3250199 · Received July 23, 2013

    Report

    Report Number
    8030665-2013-00470
    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
    KOC
    PMA / PMN Number
    K022536
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. A BATCH RECORD REVIEW WILL BE COMPLETED TO DETERMINE THE MANUFACTURING PROCESS. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ONCE THE PLANT AND CLINICAL INVESTIGATIONS ARE COMPLETE. THIS IS ONE OF 4 MDR'S SUBMITTED TO DOCUMENT THIS REPORTED EVENT. PLEASE REFERENCE THE FOLLOWING MDR NUMBERS: 2937457-2013-00099; 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 HAS 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
    344313 TWITTER REVERSE FLOW DEVICE KOC FRESENIUS MEDICAL CARE NORTH AMERICA COMBISET ACCESS FLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R ACID CONCENTRATE| FRESENIUS 2008K HEMODIALYSIS MACHINE| DIALYZER