BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 6028287 · Received October 13, 2016

    Report

    Report Number
    1225714-2016-00138
    Event Type
    Death
    Date Received
    October 13, 2016
    Date of Event
    October 13, 2014
    Report Date
    November 28, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE-NA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE INITIAL REPORTER AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THIS EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED ACUTE CARDIAC ARREST AND EXPIRED, WHICH IS ALLEGED TO HAVE BEEN DUE TO THE USE OF THE PRODUCT.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED ACUTE CARDIAC ARREST AND EXPIRED, WHICH IS ALLEGED TO HAVE BEEN DUE TO THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678086 GRANUFLO DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO FRESENIUS MEDICAL CARE-NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L