BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE

    MDR report key: 2141193 · Received June 22, 2011

    Report

    Report Number
    1713747-2011-00022
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    February 26, 2011
    Report Date
    June 22, 2011
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS DIALYZED IN HOSPITAL ON (B)(6) 2011 AND WAS NOTED TO HAVE SHORTNESS OF BREATH AT THE START OF TREATMENT. THE PATIENT APPEARED IN MILD DISTRESS WITH COMBINATION OF ANXIETY AS WELL AS CHF. SHE HAD CRACKLES IN HER CHEST AND SEEMED ANXIOUS AT STARTING HEMODIALYSIS BUT THE PHYSICIAN FELT IT WAS A POSSIBLE DIALYZER REACTION. TREATMENT WAS STOPPED AND THE PATIENT WAS TREATED WITH SOLU CORTEF 100MG AS WELL AS ATIVAN 0.5 MG IV. ADDITIONALLY, THE DIALYZER WAS RINSED WITH 2 LITERS OF NORMAL SALINE. DIALYSIS RESTARTED AND WENT UNEVENTFUL FOR THE REMAINDER OF THE DIALYSIS TREATMENT. NO FURTHER INFORMATION WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 160NRE HEMODIALYSIS DIALYZER FJI OGDEN MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention