BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 2850944 · Received November 15, 2012

    Report

    Report Number
    1225714-2012-00012
    Event Type
    Death
    Date Received
    November 15, 2012
    Date of Event
    July 26, 2009
    Report Date
    October 16, 2012
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THE DECEDENT EXPERIENCED METABOLIC ALKALOSIS, HYPOTENSION, HYPERKALEMIA AND CARDIAC ARREST, AND SUBSEQUENTLY EXPIRED ON (B)(6) 2009 AFTER THE USE OF THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATURALYTE DRY ACID CONCENTRATE FOR BICARBONATE DIALYSIS KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death