BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSM

    MDR report key: 1940409 · Received December 20, 2010

    Report

    Report Number
    1713747-2010-00054
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    September 9, 2010
    Report Date
    December 20, 2010
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPORT HAS BEEN RECEIVED THAT REPORTED REGARDING AN EVENT THAT OCCURRED TO A HEMODIALYSIS PATIENT. A CALL HAS BEEN PLACED TO THE DIALYSIS FACILITY FOR ADDITIONAL INFORMATION AND CONFIRMATION REGARDING THE REPORT. IT WAS REPORTED THAT THIS PATIENT WAS HAVING AN EVENT OF HIVES, ITCHING, MULTIPLE RED SPOTS ON DIFFERENT PART OF BODY, SHORTNESS OF BREATH, FLUSHED FACE, AND CHEST PAIN. THE PATIENT WAS GIVEN A DOSE OF INTRAVENOUS DIPHENHYDRAMINE AND THEN THEY TRIED TO CONTINUE THE TREATMENT WHEN THE ALLERGIC REACTION PROGRESSED. THE PATIENT WAS TRANSFERRED TO THE ER FOR FURTHER EVALUATION. THE PATIENT WAS DISCHARGED; HOWEVER, IT WAS LEARNED THAT THIS PATIENT HAS SINCE TRANSFERRED TO A DIFFERENT DIALYSIS FACILITY WHERE REUSE IS UTILIZED. ADDITIONALLY, IT WAS LEARNED THAT A DIFFERENT BRAND OF MANUFACTURED DIALYZER IS BEING USED AT THIS TIME. CURRENTLY, THIS PATIENT CONTINUES TO HAVE THESE SYMPTOMS DESPITE SWITCHING TO REUSE AND A DIFFERENT BRAND OF DIALYZER. REPORTEDLY, THE PATIENT ALSO RECEIVES DOSING OF DIPHENHYDRAMINE AND PREDNISONE. THERE IS NO SAMPLE AND THE LOT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 160NRE DIALYZER FINISHED ASSM OPTIFLUX 160NRE DIALYZER FINISHED ASSY. FJI OGDEN MANUFACTURING NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| O| R