BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 160NRE DIALYZER FINISHED ASSY.

    MDR report key: 6206006 · Received December 27, 2016

    Report

    Report Number
    1713747-2016-00584
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 27, 2016
    Manufacturer
    OGDEN MANUFACTURING PLANT
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT IS NOT CONFIRMED AS THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR MANUFACTURER EVALUATION. AS SUCH, A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED LOT. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THE LOT PASSED ALL RELEASE CRITERIA. REVIEW OF THE BATCH PRODUCTION RECORD (BPR) DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT.

    Description of Event or Problem · 1

    A USER FACILITY REPORTED THAT A BLOOD LEAK OCCURRED IMMEDIATELY AFTER INITIATION OF THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS NOTED AS BEING AN INTERNAL DIALYZER LEAK. THE MACHINE ALARMED AND BLOOD WAS VISUALLY OBSERVED IN THE DIALYSATE COMPARTMENT AND THE HANSEN OF THE DIALYZER. THEREFORE, BLOOD TEST STRIPS WERE NOT USED TO CONFIRM THE PRESENCE OF BLOOD. NO DIALYZER DAMAGE WAS VISIBLE. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS NOTED AS BEING APPROXIMATELY 300 CC. NO PATIENT ADVERSE EFFECTS WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT COMPLETED TREATMENT WITH A NEW SET-UP ON A DIFFERENT MACHINE. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT WAS DISCARDED BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854981 OPTIFLUX 160NRE DIALYZER FINISHED ASSY. DIALYZER, CAPILLARY, HOLLOW FIBER FJI OGDEN MANUFACTURING PLANT 16KU01004

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR FRESENIUS 2008K HEMODIALYSIS MACHINE| FRESENIUS BLOODLINE