BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 4832862 · Received June 9, 2015

    Report

    Report Number
    1225714-2015-03802
    Event Type
    Death
    Date Received
    June 9, 2015
    Date of Event
    February 5, 2010
    Report Date
    June 3, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K981043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THIS EVENT. THE PRODUCT WAS NOT RETURNED AND LOT OR SERIAL NUMBER IS NOT AVAILABLE. THE PRODUCT IS MANUFACTURED TO MEET THE ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION REQUIREMENTS USING VALIDATED PROCESSES, AND RELEASED BASED ON A DETERMINATION THAT THE FINISHED PRODUCT MEETS THOSE REQUIREMENTS. PRODUCT IS NOT RELEASED IF IT DOES NOT MEET REQUIREMENTS OR IS NONCONFORMING. COMPLAINT CANNOT BE CONFIRMED BASED ON THE CURRENT INFORMATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY ADDITIONAL INFORMATION.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE PATIENT EXPERIENCED CARDIAC ARRHYTHMIA, ISCHEMIA AND SUBSEQUENTLY EXPIRED. THIS IS ALLEGED TO HAVE BEEN CAUSED BY EXPOSURE TO THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372855 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L