BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3771118 · Received December 19, 2013

    Report

    Report Number
    1225714-2013-03838
    Event Type
    Death
    Date Received
    December 19, 2013
    Date of Event
    January 17, 2013
    Report Date
    May 12, 2016
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) OF TWO EVENTS REPORTED FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS #1225714-2013-03838, 03839, 03840 AND 03841.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ADVISED THAT THE PATIENT EXPERIENCED METABOLIC ALKALOSIS AND CARDIAC ARREST. REQUESTS FOR EVENT CLARIFICATION AND CIRCUMSTANCES SURROUNDING THE EVENT HAVE BEEN MADE AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. THIS IS ONE OF FIVE DEVICE REPORTS THAT ARE ASSOCIATED WITH THIS EVENT; ASSOCIATED MANUFACTURER REPORT NUMBERS: 1225714-2013-03838, 1225714-2013-03839, 1225714-2013-03840, 1225714-2013-03841 AND 2937457-2016-0051 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 DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON (B)(6) 2013 AND SUBSEQUENTLY EXPIRED ON (B)(6) 2013 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667982 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death