BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 8883050 · Received August 12, 2019

    Report

    Report Number
    2937457-2019-02517
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 6, 2019
    Report Date
    August 12, 2019
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    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. AN EXTERIOR VISUAL INSPECTION OF THE RETURNED CYCLER SHOWED NO SIGNS OF PHYSICAL DAMAGE. UPON POWER UP, THE CYCLER TOUCH SCREEN TEST FAILED. WHEN POWERING ON THE CYCLER, THE OK, STOP AND UP/DOWN ARROW PUSH BUTTONS ILLUMINATED, HOWEVER THE FRONT PANEL TOUCH SCREEN REMAINED BLANK. IT WAS IDENTIFIED THAT THE CAUSE FOR THE BLANK SCREEN WAS DUE TO AN INTERNAL SHORT PRESENT TRANSFORMER (T1) ON THE INVERTER BOARD. THE INVERTER BOARD IS LOCATED ON THE REAR OF THE TOUCH SCREEN. A KNOWN GOOD INVERTER BOARD WAS INSTALLED AND THE DISPLAY BECAME FULLY OPERATIONAL. AN INTERNAL VISUAL INSPECTION OF THE RETURNED CYCLER ENCOUNTERED NO OTHER DISCREPANCIES. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCE'S 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 · 1

    A PERITONEAL DIALYSIS (PD) PATIENT CONTACTED FRESENIUS TECHNICAL SUPPORT TO REPORT THEY CANNOT TURN ON THE CYCLER. WHILE IN TREATMENT, THE CYCLER POWERED DOWN AT AN UNKNOWN STEP. THE PATIENT TRIED TO POWER ON THE CYCLER, BUT IT DID NOT TURN ON. THE KEYPAD DID NOT LIGHT UP. THE CYCLER WAS PLUGGED DIRECTLY INTO A WALL OUTLET THAT WAS SHARED WITH THE MODEM. THE MODEM POWERED ON. THE FRESENIUS TECHNICAL SUPPORT REPRESENTATIVE ISSUED A REPLACEMENT CYCLER AND ADVISED THE PATIENT TO DISCONTINUE USING THE MACHINE. ALTERNATIVE TREATMENT WAS AVAILABLE. UPON FOLLOW UP, THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) CONFIRMED THAT THERE WERE NO ADVERSE EVENTS OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT DID NOT COMPLETE TREATMENT. THE CYCLER WAS RETURNED TO THE MANUFACTURER. UPON PHYSICAL EVALUATION OF THE CYCLER BY THE MANUFACTURER, EVIDENCE OF AN INTERNAL SHORT ON THE TRANSFORMER ON THE INVERTER BOARD WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679294 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING LIBERTY SELECT CYCLER 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 DELFLEX PD FLUID| LIBERTY CYCLER SET