BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 4832844 · Received June 9, 2015

    Report

    Report Number
    1225714-2015-03811
    Event Type
    Death
    Date Received
    June 9, 2015
    Date of Event
    January 2, 2005
    Report Date
    June 3, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THE EVENT. THE PRODUCT WAS NOT RETURNED AND LOT OR SERIAL NUMBER IS NOT AVAILABLE. THE PRODUCT IS MANUFACTURED TO MEET THE ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION REQUIREMENTS USING VALIDATED PROCESSES, AND RELEASED BASED ON A DETERMINATION THAT THE FINISHED PRODUCT MEETS THOSE REQUIREMENTS. PRODUCT IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. COMPLAINT CANNOT BE CONFIRMED BASED ON THE CURRENT INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGES THAT THE PT EXPERIENCED SUDDEN CARDIAC EVENT AND EXPIRED APPROXIMATELY TWO WEEKS LATER, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PT'S EXPOSURE TO THE PRODUCT ADMINISTERED DURING HEMODIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372851 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L