BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 1983917 · Received February 4, 2011

    Report

    Report Number
    1713747-2011-00004
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    January 6, 2011
    Report Date
    February 4, 2011
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED THAT INITIALLY HAS REPORTED A PT WITH PRIOR USE OF THIS DIALYZER HAD A FIRST KNOWN REACTION. THE SYMPTOMS REPORTED WERE UNCONTROLLABLE ITCHING AND RHINORRHEA. THE SYMPTOMS OCCURRED DURING TREATMENT. THE PT WAS GIVEN 25MG INTRAVENOUS DOSE OF DIPHENHYDRAMINE. IT WAS REPORTED NO HYPERSENSITIVITY REACTION IN THE PAST. THE PT HAS BEEN PRESCRIBED A NEW DIALYZER. IT WAS REPORTED THAT THE PT IS SLIGHTLY IMPROVED WITH USE OF THE NEW DIALYZER. ADDITIONALLY IN SPEAKING WITH THE REPORTER OF THE EVENT, IT WAS LEARNED THAT THE PT HAD ITCHING OVER A PERIOD OF TIME. IT WAS ALSO DETERMINED THAT THIS PT WAS COUNSELED REGARDING ELEVATED BOTH ELEVATED PHOSPHORUS AND CALCIUM AND WAS ENCOURAGED TO GET "BACK ON TRACK". THERE IS NO SAMPLE AND THE LOT IS UNK. THE PT WILL BE TRANSFERRING TO HOME HEMODIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER FJI FRESENIUS MEDICAL CARE NORTH AMERICA NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other