BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 20652429 · Received November 11, 2024

    Report

    Report Number
    0002937457-2024-01515
    Event Type
    Malfunction
    Date Received
    November 11, 2024
    Date of Event
    June 26, 2024
    Report Date
    November 11, 2024
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K222318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGNS OF PHYSICAL DAMAGE. THERE WERE VISUAL INDICATIONS OF DRIED FLUID WITHIN THE CASSETTE COMPARTMENT ON THE PUMP. THERE WAS NO VISUAL INDICATION OF PARTICULATES WITHIN THE CASSETTE AREA. THERE WERE NO BURRS OR SHARP EDGES IN CASSETTE AREA THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. TOUCH SCREEN TEST FAILED - WHEN POWERING ON THE CYCLER THE ¿OK, STOP, AND UP/DOWN ARROWS PUSH BUTTONS¿ ILLUMINATED, HOWEVER THE FRONT PANEL DISPLAY REMAINED BLANK. AN INTERNAL INSPECTION OF THE CYCLER FOUND A SHORT ON T1 OF THE INVERTER BOARD WITH LOT CODE 1917 WHICH REFLECTS THE TRANSFORMER HAS P155 INSULATION THICKNESS. THE INVERTER BOARD IS LOCATED ON THE REAR OF THE FRONT PANEL ASSEMBLY. A KNOWN GOOD INVERTER BOARD WAS INSTALLED AND THE DISPLAY BECAME OPERATIONAL. THERE WERE VISUAL INDICATIONS OF DRIED FLUID UNDER THE PUMP ASSEMBLY ON THE BOTTOM COVER. THE CAUSE OF THE OBSERVED DRIED FLUID COULD NOT BE DETERMINED. MUSHROOM HEAD CHECK PASSED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND VERIFIED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. UPON COMPLETION OF THE EVALUATION, THE REPORTED ISSUE WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE AN INTERNAL SHORT ON TRANSFORMER ON THE INVERTER BOARD. THE CYCLER WAS REFURBISHED FOLLOWING THE EVALUATION.

    Description of Event or Problem · 0

    A CONTACT OF A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT THE LIBERTY SELECT CYCLER HAD A BURNING SMELL. ACCORDING TO THE REPORTER, WHEN THEY TURNED ON THE CYCLER YESTERDAY, THERE WAS A PLASTIC BURNING SMELL COMING FROM THE CYCLER. PLEASE REFER TO QSN # (B)(4) REGARDING PREVIOUS CALLS RELATED TO THE SAME ISSUE. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE CONTACT THE CYCLER WOULD BE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, NO HARM OR ADVERSE EVENT REPORTED. THE CYCLER WAS RETURNED. UPON PHYSICAL EVALUATION OF THE CYCLER BY THE MANUFACTURER, IT WAS IDENTIFIED THAT THE TRANSFORMER ON THE INVERTER BOARD HAD AN INTERNAL SHORT. A PHONE CALL AND WRITTEN ATTEMPT HAVE BEEN MADE TO GATHER ADDITIONAL INFORMATION, BUT FRESENIUS HAS NOT RECEIVED ANY FURTHER DETAILS REGARDING THE REPORTED EVENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889458 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown