BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 4101398 · Received September 3, 2014

    Report

    Report Number
    1225714-2014-10364
    Event Type
    Death
    Date Received
    September 3, 2014
    Date of Event
    June 30, 2012
    Report Date
    August 18, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) FOR THE SAME PT INVOLVING TWO SEPARATE PRODUCTS.

    Additional Manufacturer Narrative · 1

    THE INITIAL INFORMATION RECEIVED ALLEGED A FATAL CARDIAC EVENT. HOWEVER, ADDITIONAL INFORMATION RECEIVED ALLEGED THAT THE PATIENT EXPERIENCED RESPIRATORY FAILURE, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PRODUCT ADMINISTERED TO THE PATIENT FOR DIALYSIS TREATMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. THIS IS ONE OF TWO DEVICE REPORTS FOR THIS EVENT. ASSOCIATED MANUFACTURER REPORT NUMBERS: 1225714-2014-10364 AND 1225714-2014-10365.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2012 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535895 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death