BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 3190386 · Received June 21, 2013

    Report

    Report Number
    1713747-2013-00201
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    March 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REPORTED REACTIONS SUCH AS HEADACHE, NAUSEA, VOMITING AND A HOLLOW TYPE FEELING IN HIS EARS WITH THE USE OF A FRESENIUS DIALYZER. THE PATIENT WENT THROUGH MULTIPLE TREATMENTS AND DID NOT REPORT THE REACTIONS UNTIL 25 TREATMENTS WERE COMPLETED. TREATMENT SHEETS FOR THE PATIENT'S LAST TREATMENT WITH THE USE OF A FRESENIUS DIALYZER WERE PROVIDED. THE TREATMENT SHEETS INDICATE THAT THE PATIENT HAD NO COMPLAINTS DURING TREATMENT AND COMPLETED TREATMENT WITH NO ISSUES. CURRENTLY, IT IS UNKNOWN IF THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PATIENT WAS REPORTED TO HAVE CHANGED MANUFACTURER OF THE DIALYZER AND IS DOING BETTER WITH LESS HEADACHES. BASED ON THE AVAILABLE INFORMATION, NO DEFINITIVE CONCLUSION CAN BE DRAWN. PLEASE REFERENCE MDR#'S: 1713747-2013-00200 THROUGH 1713747-2013-00224.

    Description of Event or Problem · 1

    THE PATIENT REPORTED TO HIS CLINIC THAT HE HAD BEEN EXPERIENCING MULTIPLE REACTIONS TO THE FRESENIUS DIALYZER SINCE THE START OF HIS TREATMENT. THE PATIENT'S SYMPTOMS INCLUDED HEADACHES, NAUSEA, VOMITING, AND A HOLLOW FEELING IN THE EARS. THE PATIENT BEGAN TREATMENT ON (B)(6) 2013 AND CONTINUED TREATMENT 3 TIMES PER WEEK UNTIL HIS LAST TREATMENT WITH A FRESENIUS DIALYZER ON (B)(6) 2013. THE PATIENT'S DIALYZER PRESCRIPTION WAS CHANGED TO A NON-FRESENIUS PRODUCT. THE PATIENT IS REPORTED TO BE DOING BETTER AND EXPERIENCING LESS HEADACHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283917 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. FJI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention FRESENIUS 2008K2