BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 3496483 · Received November 18, 2013

    Report

    Report Number
    1225714-2013-03599
    Event Type
    Death
    Date Received
    November 18, 2013
    Date of Event
    February 4, 2012
    Report Date
    November 8, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDRS # 1225714-2013-03598, 03599.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO DEVICE REPORTS RELATED TO THIS EVENT. ASSOCIATED MFR REPORT NUMBERS ARE 1225714-2014-003598 AND 1225714-2014-03599. ADD'L INFO HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED ON AN UNKNOWN DATE AFTER THE USE OF THE PRODUCT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT THE PATIENT EXPERIENCED A SUDDEN CARDIAC EVENT. THREE DAYS LATER, THE PATIENT EXPERIENCED ANOTHER SUDDEN CARDIAC EVENT AND EXPIRED ON THE SAME DAY, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY THE PATIENT'S EXPOSURE TO THE PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595019 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death