BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3925177 · Received June 18, 2014

    Report

    Report Number
    1225714-2014-04721
    Event Type
    Death
    Date Received
    June 18, 2014
    Date of Event
    February 12, 2012
    Report Date
    May 20, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS 1225714-2014-04721 AND 1225714-2014-04722.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED METABOLIC ALKALOSIS, HYPOTENSION, HYPOKALEMIA, A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON (B)(6) 2012 AFTER USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358237 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Death