BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOM COMBI SET

    MDR report key: 4999703 · Received August 6, 2015

    Report

    Report Number
    8030665-2015-00350
    Event Type
    Malfunction
    Date Received
    August 6, 2015
    Date of Event
    July 20, 2015
    Report Date
    July 21, 2015
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    FJK
    PMA / PMN Number
    K962081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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

    VISUAL EXAMINATION CONFIRMED THE ALLEGED PROBLEM. AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. DURING VISUAL EXAMINATION, A CUT WAS NOTICED ON THE PORT OF THE VENOUS CHAMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS ALSO CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPEC.

    Description of Event or Problem · 1

    A HEMODIALYSIS USER FACILITY REPORTED DURING TREATMENT A BLOOD LEAK OCCURRED. THE LEAK WAS REPORTED TO BE AN EXTERNAL LEAK LOCATED ON THE COMBI-SET BLOODLINE. THE MACHINE DID NOT ALARM. ESTIMATED BLOOD LOSS WAS 80.5CC. THE PATIENT HAD NO ADVERSE EFFECTS AND NO MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT COMPLETED TREATMENT. SAMPLE IS AVAILABLE FOR MANUFACTURING EVALUATION AND HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520665 CUSTOM COMBI SET FJK FRESENIUS MEDICAL CARE 15DR01201

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR