BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 8073143 · Received November 15, 2018

    Report

    Report Number
    2937457-2018-03393
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 21, 2018
    Report Date
    November 15, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K171652
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGN OF PHYSICAL DAMAGE. THE TOUCH SCREEN TEST FAILED - WHEN POWERING ON THE CYCLER THE ¿OK, STOP, AND UP/DOWN ARROWS PUSH BUTTONS DID NOT ¿ILLUMINATE, AND THE FRONT PANEL TOUCH SCREEN REMAINED BLANK. AN INTERNAL INSPECTION OF THE CYCLER FOUND TRANSFORMER (T1) ON THE ¿INVERTER BOARD¿ TO BE BURNT. THE INVERTER BOARD IS LOCATED ON THE REAR OF THE TOUCH SCREEN. A KNOWN GOOD INVERTER BOARD WAS INSTALLED AND THE CYCLER BECAME OPERATIONAL. REMOVED FUNCTIONING INVERTER BOARD AT THE COMPLETION OF THE INVESTIGATION. THERE WERE VISUAL INDICATIONS OF DRIED FLUID WITHIN THE CASSETTE COMPARTMENT DURING THE INTERNAL INSPECTION. NO BURRS OR SHARPS IN CASSETTE AREA THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. THE CAUSE OF THE OBSERVED DRIED FLUID COULD NOT BE DETERMINED. GLUCOSE TEST FAILED. THE 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 A BURNT TRANSFORMER ON THE INVERTER BOARD. THE CYCLER WAS REFURBISHED FOLLOWING THE EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREEN OF A PATIENT¿S LIBERTY SELECT CYCLER WAS BLANK UPON POWER UP. THE POWER CORD WAS PROPERLY CONNECTED IN BOTH ENDS. THE CYCLER WAS REBOOTED AND THE OK AND STOP BUTTONS LIT UP, HOWEVER, THE SCREEN REMAINED BLANK. AT THAT POINT IN TIME, THE TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE PATIENT TO DISCONTINUE USE OF THE CYCLER AND TO NOTIFY THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF THE EVENT. THE PATIENT DID NOT COMPLETE TREATMENT ON THE NIGHT OF THE EVENT. THERE WERE NO ADVERSE EVENTS, INJURIES, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE EVENT. THE CYCLER WAS RETURNED TO THE MANUFACTURER AND A REPLACEMENT CYCLER WAS PROVIDED AND RECEIVED. UPON PHYSICAL EVALUATION OF THE CYCLER BY THE MANUFACTURER, IT WAS IDENTIFIED THAT THE TRANSFORMER ON THE INVERTER BOARD WAS BURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913466 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING LIBERTY SELECT CYCLER 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1