BEUDAMED
    FDA Adverse Event Death Summary report: N

    GRANUFLO

    MDR report key: 3093991 · Received May 1, 2013

    Report

    Report Number
    1225714-2013-00784
    Event Type
    Death
    Date Received
    May 1, 2013
    Date of Event
    June 20, 2008
    Report Date
    April 9, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT IS ON THE SAME PT INVOLVING TWO SEPARATE PRODUCTS AND ASSOCIATED WITH MEDWATCH #1225714-2013-00785.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THIS EVENT. ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1225714-2013-00784 AND 1225714-2013-00785.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON OR ABOUT (B)(6) 2008, AFTER THE USE OF THE PRODUCT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION AND SUDDEN CARDIAC ARREST FOLLOWED BY SYMPTOMS OF POST CARDIAC ARREST SYNDROME RESULTING THE PATIENT TO EXPIRE A WEEK LATER, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PRODUCT ADMINISTERED TO THE PATIENT FOR DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189119 GRANUFLO DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death