BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3840764 · Received May 13, 2014

    Report

    Report Number
    1225714-2014-02567
    Event Type
    Death
    Date Received
    May 13, 2014
    Date of Event
    April 9, 2012
    Report Date
    April 17, 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 FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDR#1225714-2014-02567 AND 1225714-2014-02568.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THIS EVENT. ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1225714-2014-02567 AND 1225714-2014-02568. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THE DECEDENT EXPERIENCED AN UNSPECIFIED INJURY AND SUBSEQUENTLY EXPIRED ON AN UNKNOWN DATE AFTER USE OF THE PRODUCT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT EXPERIENCED ALKALOSIS, CARDIAC ARRHYTHMIAS, SUDDEN CARDIAC ARREST, AND SUDDEN CARDIAC DEATH, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285430 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death