BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 2103799 · Received May 24, 2011

    Report

    Report Number
    1713747-2011-00014
    Event Type
    Injury
    Date Received
    May 24, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 24, 2011
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    THE PATIENT IS AN (B)(6) YEAR OLD MALE WEIGHING (B)(6) KG WITH A HISTORY OF HYPERTENSION AND CAD WHO RECEIVES HIS DIALYSIS TREATMENT AT THE HIGHLAND LIVING CENTER AND IS OVERSEEN BY (B)(6) HOSPITAL. A SUSPECTED DIALYZER REACTION WAS REPORTED TO US ON (B)(6) 2011, REGARDING AN EVENT WHICH OCCURRED ON (B)(6) 2011. APPROXIMATELY 9 MINUTES INTO TREATMENT, THE PATIENT EXPERIENCED A LOC WITH A NEW ONSET OF SEIZURE ACTIVITY LASTING FOR A 5 MINUTE PERIOD. DIALYSIS TREATMENT WAS STOPPED AND A 200CC BOLUS OF NORMAL SALINE WAS ADMINISTERED. AN IMPROVEMENT WAS NOTED IN THE LOC, HOWEVER, THE PATIENT WAS TRANSPORTED TO THE HOSPITAL AND ADMITTED WITH A DIAGNOSIS OF INCREASED HEART RATE AND LOC. HE WAS DISCHARGED IN STABLE CONDITION AND NOW RECEIVES HIS DIALYSIS TREATMENT WITH THE USE OF ANOTHER BRAND OF DIALYZER AND HAS HAD NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. HEMODIALYSIS DIALYZER FJI OGDEN MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R