BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4142614 · Received October 2, 2014

    Report

    Report Number
    2937457-2014-02805
    Event Type
    Injury
    Date Received
    October 2, 2014
    Date of Event
    August 12, 2014
    Report Date
    September 3, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT FACILITY WAS UNABLE TO PROVIDE A SAMPLE FOR EVALUATION. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT PHYSICAL EXAMINATION OF THE COMPLAINT SAMPLE. 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. BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE POST MARKET CLINICAL DEPARTMENT IS IN THE PROCESS OF REQUESTING PATIENT MEDICAL RECORDS AND TREATMENT DATA INFORMATION REGARDING THE REPORTED PERITONITIS DIAGNOSIS AND TREATMENT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING FOLLOW UP OF AN UNRELATED EVENT, A PERITONEAL DIALYSIS REGISTERED NURSE REPORTED THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2014 DUE TO A BREACH IN ASEPTIC TECHNIQUE (THE END OF ONE OF THE LINES CAME IN CONTACT WITH THE PATIENT'S CLOTHING). REPORTEDLY, THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE PERITONITIS HAS RESOLVED. EFFLUENT IS CURRENTLY CLEAR AND THE PATIENT CONTINUES ON CONTINUOUS CYCLING PERITONEAL DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615409 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LIBERTY CYCLER CASSETTE| FRESENIUS PD SOLUTION