BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 4948905 · Received July 27, 2015

    Report

    Report Number
    1225714-2015-05592
    Event Type
    Death
    Date Received
    July 27, 2015
    Date of Event
    December 1, 2011
    Report Date
    July 17, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THIS EVENT. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED THREE SUDDEN CARDIAC EVENTS APPROXIMATELY THREE MONTHS AND ONE MONTH APART RESPECTIVELY. SUBSEQUENTLY, APPROXIMATELY SIX MONTHS AFTER THE FIRST ONSET OF THE SUDDEN CARDIAC EVENTS THE PATIENT EXPERIENCED ANOTHER SUDDEN CARDIAC EVENT AND EXPIRED THE SAME DAY; ALL OF WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PATIENT'S EXPOSURE TO THE PRODUCT DURING DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485710 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L