BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NATURALYTE

    MDR report key: 3960067 · Received July 17, 2014

    Report

    Report Number
    3005162618-2014-00009
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 11, 2014
    Report Date
    June 16, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K070177
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYS LEVEL INVESTIGATION HAS BEEN OPENED TO EVALUATE WHETHER OR NOT ANY DEVICES IN USE CAUSED, CONTRIBUTED OR WERE A FACTOR IN THESE EVENT. MED RECORDS HAVE BEEN REQUESTED FOR THIS EVENT. BASED ON THE INFO RECEIVED IT IS UNDETERMINED WHETHER OR NOT ANY OF THE DEVICES CAUSED OR CONTRIBUTED TO THIS EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF POST MARKET SURVEILLANCE CLINICAL STAFF'S ASSESMENT OF THE REPORTED INFO AND THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT CODED DURING TREATMENT AT THE HOSP IN THE IN-PT ACUTE UNIT. NO OTHER INFO REGARDING THIS EVENT IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417798 NATURALYTE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening OPTIFLUX DIALYZER, COMBISET BLOODLINES| FRESENIUS 2008K2 HEMODIALYSIS SYS,