BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 3240909 · Received July 17, 2013

    Report

    Report Number
    1713747-2013-00266
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 20, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVAL AND THE COMPLAINT IS NOT CONFIRMED. VISUAL EXAMINATION DID NOT IDENTIFY ANY DEFECTS THAT WOULD HAVE ALLOWED BLOOD TO ENTER THE DIALYSATE COMPARTMENT DURING TREATMENT. 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. PLEASE REFERENCE MDRS # 1713747-2013-00264 AND 1713747-2013-00265.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT WAS BEING DIALYZED IN THE INTENSIVE CARE UNIT. AND EXPERIENCED BLOOD LEAKS. THE PTS BLOOD WAS SUCCESSFULLY RETURNED AFTER EACH OCCURRENCE. THE PT'S ESTIMATED BLOOD LOSS WAS 100 CCS OVER THE 3 OCCURRENCES. SAMPLE WAS RETURNED TO THE MANUFACTURER FOR MANUFACTURING REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331997 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. FJI FRESENIUS MEDICAL CARE NORTH AMERICA 13AU06022

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR FRESENIUS 2008K HEMODIALYSIS MACHINE| FRESENIUS BLOODLINE