BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 8650231 · Received May 29, 2019

    Report

    Report Number
    2937457-2019-01711
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    April 30, 2019
    Report Date
    May 29, 2019
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. THE REPORTED BURNING SMELL AND DISTORTED DISPLAY WERE NOT CONFIRMED. HOWEVER, A BLANK SCREEN WAS ENCOUNTERED. 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 ON TRANSFORMER (T1) OF 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 HISTORY RECORD FOUND A PREVIOUS BLANK SCREEN WAS ENCOUNTERED DUE TO A DEFECTIVE INVERTER BOARD. THE INVERTER BOARD WAS REPLACED TO FIX THE ISSUE. UPON COMPLETION OF THE EVALUATION, THE REPORTED ISSUE WAS CONFIRMED AND THE CAUSE WAS DETERMINED TO BE AN INTERNAL SHORT ON THE TRANSFORMER OF 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 DISTORTED AND A BURNING SMELL WAS COMING FROM THE CYCLER DURING THEIR PERITONEAL DIALYSIS (PD) TREATMENT. THE POWER CORD WAS PROPERLY CONNECTED IN BOTH ENDS AND CYCLER PLUGGED DIRECTLY INTO A THREE PRONG WALL OUTLET THAT WAS SHARED. THE OK AND STOP KEYS WERE NOT ON AND THE SCREEN REMAINED DISTORTED. 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. A REPLACEMENT CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION, AN OLD CYCLER OR MANUALS WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT STATED THAT THERE WERE NO SPARKS, FIRE AND/OR SMOKE ASSOCIATED WITH THE BURNING SMELL. THE PATIENT CONFIRMED THAT TREATMENT WAS COMPLETED ON THE OLD CYCLER AND THERE WERE NO ADVERSE EVENTS OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED 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 THERE WAS AN INTERNAL SHORT ON THE TRANSFORMER OF THE INVERTER BOARD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442570 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

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