BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FRESENIUS COMBISET 2008

    MDR report key: 3960070 · Received July 17, 2014

    Report

    Report Number
    8030665-2014-00553
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 11, 2014
    Report Date
    June 16, 2014
    Manufacturer
    FRESENIUS MED CARE
    Product Code
    FJK
    PMA / PMN Number
    K926081
    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 THIS 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 THE POST MARKET SURVEILLANCE CLINICAL STAFF'S ASSESSMENT 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
    417799 FRESENIUS COMBISET 2008 FJK FRESENIUS MED CARE CUSTOM COMBISET 2008

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening