BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NR DIALYZER FINISHED ASSEMBLY

    MDR report key: 4961977 · Received July 31, 2015

    Report

    Report Number
    1713747-2015-00351
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 13, 2015
    Report Date
    July 14, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    FJI
    PMA / PMN Number
    K002277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT OF INTERNAL DIALYZER BLOOD LEAK IS NOT CONFIRMED. A COMPLAINT SAMPLE HAS NOT BEEN RECEIVED FOR MANUFACTURER EVALUATION. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT PHYSICAL EXAMINATION OF THE COMPLAINT SAMPLE. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY HAS REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS REPORTED TO BE AN INTERNAL DIALYZER LEAK. THE MACHINE DID NOT ALARM. TEST STRIPS WERE USED TO CONFIRM THE LEAK. ESTIMATED BLOOD LOSS WAS 200ML. THE PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. SAMPLE IS AVAILABLE FOR MANUFACTURING EVALUATION AND HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498842 OPTIFLUX 180NR DIALYZER FINISHED ASSEMBLY FJI FRESENIUS MEDICAL CARE 15DU06013

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR