BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 8883150 · Received August 12, 2019

    Report

    Report Number
    2937457-2019-02519
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 4, 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
    KS, 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 ON THE 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. THE FUNCTIONING INVERTER BOARD WAS REMOVED AT THE COMPLETION OF THE INVESTIGATION. A FIFTEEN MINUTE SELF-TEST/TREATMENT SIMULATED TREATMENT WAS PERFORMED. SWITCH THE CYCLER POWER ¿OFF¿ THEN ¿ON¿ DURING TREATMENT TO VERIFY ¿POWER FAIL RECOVERY¿ OPERATES AS INTENDED. THE CYCLER WAS POWERED ¿OFF¿ AND ¿ON¿ DURING THE TREATMENT (DRAIN 0) AND THE ¿POWER FAIL RECOVERY¿ PERFORMED AS INTENDED. 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-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 OF THE 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 WENT BLANK DURING AN UNKNOWN POINT OF THEIR PERITONEAL DIALYSIS (PD) TREATMENT. THE POWER CORD WAS PLUGGED INTO A WORKING OUTLET. THE OK AND STOP KEYS WERE ON AFTER REBOOTING, HOWEVER THE SCREEN REMAINED BLANK. REBOOTING THE CYCLER DID NOT RESTORE DISPLAY AND AN UNKNOWN ALARM WAS REPORTED. AT THAT POINT IN TIME, THE TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE PATIENT CONTACT 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 THE PATIENT WAS ABLE TO COMPLETE TREATMENT USING MANUALS. UPON FOLLOW UP, THE PATIENT CONFIRMED THAT THERE WERE NO ADVERSE EVENTS OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS NOT ABLE TO COMPLETE TREATMENT. 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 HAD AN INTERNAL SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680167 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