BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 2792269 · Received October 12, 2012

    Report

    Report Number
    1713747-2012-00175
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 8, 2012
    Report Date
    September 18, 2012
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS RECEIVED, REVIEW WAS PERFORMED.

    Description of Event or Problem · 1

    ON (B)(6) 2012 WHILE RECEIVING A HEMODIALYSIS TREATMENT A POTENTIAL DIALYZER REACTION OCCURRED, THIS WAS DISCOVERED WHILE REVIEWING MEDICAL RECORDS FOR ANOTHER EVENT. THE HEMODIALYSIS PATIENT EXPERIENCED SEIZURE LIKE ACTIVITY WHICH CLINCHED EXTREMITIES, EYES AVERTED UPWARD AND A BLOCKED AIRWAY DURING A HEMODIALYSIS TREATMENT. THE HEMODIALYSIS TREATMENT WAS DISCONTINUED AND THE PATIENT WAS REINFUSED. AN ORAL AIRWAY WAS PUT IN, OXYGEN ADMINISTERED VIA AMBU BAG AND THE PATIENT WAS TRANSPORTED TO THE MEDICAL INTENSIVE CARE UNIT WHERE ALL SYMPTOMS SELF RESOLVED. THE PATIENT WAS IMMEDIATELY ALERT AND ORIENTED TIMES THREE, BECAME TALKATIVE WITH THICK SPEECH BUT CLEAR. THE HEMODIALYSIS TREATMENT WAS REINITIATED WITH AN ALTERNATIVE DIALYZER WHERE THE PATIENT COMPLETED HIS TREATMENT WITHOUT FURTHER ILL EFFECTS OR ISSUES. THE PATIENT CONTINUES HEMODIALYSIS THERAPY USING THE ALTERNATIVE DIALYZER WITHOUT PROBLEM OR ISSUE. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE FOR EVALUATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention HEMODIALYSIS MACHINE