BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 200NRE DIALYZER FINISHED ASSY.

    MDR report key: 3915438 · Received June 5, 2014

    Report

    Report Number
    1713747-2014-00271
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 8, 2014
    Report Date
    May 8, 2014
    Manufacturer
    OGDEN MANUFACTURING
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION HAS NOT YET BEEN COMPLETED. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    FACILITY REPORTED THAT TWO HOURS INTO TREATMENT, NURSE NOTICED THAT THERE APPEARED TO BE A MINOR LEAK IN DIALYZER. LEAK APPEARS TO BE COMING FROM ONE BROKEN FIBER INSIDE DIALYZER THAT STILL HAS ONE SIDE CONNECTED TO POTTING COMPOUND. THE MACHINE DID NOT ALARM. NURSE DID NOT SEE BLOOD IN DIALYSATE LINES, BUT COULD SEE BLOOD COMING OUT OF SINGLE FIBRE INSIDE DIALYZER. SHE CONFIRMED BLOOD IN THE DIALYSATE WITH SIEMENS HEMASTIX TEST STRIPS. THE RESULT CAME BACK "MODERATE" OR MEDIUM GREEN COLOR. LINES AND DIALYZER GOT REMOVED AND DISCARDED. NEW LINES GOT SETUP. MACHINE WAS PULLED AFTER TREATMENT AND BLEACHED. EBL WAS A WHOLE CIRCUIT (APPROX. 300CC'S) PATIENT HAD NO ADVERSE EFFECTS AND REQUIRED NO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328850 OPTIFLUX 200NRE DIALYZER FINISHED ASSY. FJI OGDEN MANUFACTURING 14AU04011

    Patients

    Seq Age Sex Outcome Treatment
    1 5008 HEMODIALYSIS MACHINE