BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLUX 180NRE DIALYZER FINISHED ASSY.

    MDR report key: 4091267 · Received September 5, 2014

    Report

    Report Number
    1713747-2014-00425
    Event Type
    Injury
    Date Received
    September 5, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 7, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FJI
    PMA / PMN Number
    K002761
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE FAILURE MODE CANNOT BE CONFIRMED. 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. MEDICAL RECORDS HAVE BEEN REQUESTED AND HAVE NOT BEEN RECEIVED BY THE MANUFACTURER TO DATE. UPON RECEIPT OF THE MEDICAL RECORDS, A CLINICAL INVESTIGATION WILL BE CONDUCTED AND SUPPLEMENTAL REPORT WILL BE FILED WITH THE RESULTS OF THE CLINICAL INVESTIGATIONS.

    Description of Event or Problem · 1

    A HEMODIALYSIS INPATIENT USER FACILITY REPORTED THAT DURING TREATMENT A BLOOD LEAK OCCURRED. THE RN INITIATED TREATMENT WITH IMMEDIATE BLOOD LEAK DETECTED. TREATMENT WAS STOPPED AND RESET THE LINES AND DIALYZER. THE LEAK WAS VISUALLY OBSERVED IN THE DRAIN AND THE MACHINE ALARMED. ESTIMATED BLOOD LOSS WAS 100CC'S. NO DAMAGE WAS OBSERVED ON THE DIALYZER BUT A SLIGHTLY YELLOWER COLOR WAS OBSERVED AT THE ENDS OF THE DIALYZER. PATIENT WAS ABLE TO COMPLETE TREATMENT. PATIENT WAS STABLE PRIOR TO START OF TREATMENT AND DID NOT REQUIRE INTERVENTION AT THE TIME OF THE INCIDENT; HOWEVER, THE PATIENT DID REQUIRE AN EXTRA UNIT OF BLOOD TO BE TRANSFUSED PER MD ORDER DUE TO THE UNEXPECTED BLOOD LOSS. SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546357 OPTIFLUX 180NRE DIALYZER FINISHED ASSY. FJI FRESENIUS MEDICAL CARE NORTH AMERICA 13HU02012

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention FRESENIUS 2008K MACHINE