BEUDAMED
    FDA Adverse Event Death Summary report: N

    NATURALYTE

    MDR report key: 3809850 · Received April 30, 2014

    Report

    Report Number
    1225714-2014-01902
    Event Type
    Death
    Date Received
    April 30, 2014
    Date of Event
    March 5, 2013
    Report Date
    April 2, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE EVENT (DEATH) FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS; ASSOCIATED MDR REPORTS: 1225714-2014-01901 AND 1225714-2014-01902.

    Additional Manufacturer Narrative · 1

    (B)(4).THE ADDITIONAL INFORMATION RECEIVED NOTED A DATE THAT IS FOUR DAYS AFTER THE EVENT DATE AND DATE OF DEATH IN THE INITIAL MEDWATCH REPORT. AS A RESULT, THE DATE OF DEATH AND THE EVENT DATE WILL NOT BE UPDATED UNTIL CLARIFICATION FOR THESE DATES HAS BEEN RECEIVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE SUBMITTED UPON RECEIPT ACCORDINGLY. THIS IS ONE OF TWO DEVICE REPORTS FOR THIS EVENT. THE RELATED MFR REPORT NUMBERS ARE 1225714-2014-01901 AND 1225714-2014-01902.

    Description of Event or Problem · 1

    THE PLAINTIFF'S ATTORNEY ALLEGED THAT THE DECEDENT EXPERIENCED A CARDIOVASCULAR EVENT AND SUBSEQUENTLY EXPIRED WITHIN 48 HOURS AFTER USE OF THE PRODUCT ON (B)(6) 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED: PATIENT EXPERIENCED ALKALOSIS, CARDIAC ARRHYTHMIAS, SUDDEN CARDIAC ARREST, AND SUDDEN DEATH, WHICH IS ALLEGED TO HAVE BEEN CAUSED BY PRODUCT ADMINISTERED DURING DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259571 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death