BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 4377868 · Received December 30, 2014

    Report

    Report Number
    1225714-2014-15798
    Event Type
    Death
    Date Received
    December 30, 2014
    Date of Event
    July 26, 2011
    Report Date
    December 17, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF THREE DEVICE REPORTS RELATED TO THIS EVENT. THE ASSOCIATED MANUFACTURER REPORT NUMBERS ARE 1225714-2014-15797, 1225714-2014-15798, AND 2937457-2014-03605.

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) FOR THE SAME PATIENT INVOLVING THREE SEPARATE PRODUCTS.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT ON OR ABOUT (B)(6) 2011 AND SUBSEQUENTLY EXPIRED AFTER THE USE OF THE PRODUCT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THE PATIENT EXPERIENCED ALKALOSIS, CARDIAC ARRHYTHMIAS, AND SUDDEN CARDIAC ARREST, FOUR YEARS PRIOR TO EXPIRY, 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
    859782 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death