BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 9558681 · Received January 7, 2020

    Report

    Report Number
    2937457-2020-00024
    Event Type
    Death
    Date Received
    January 7, 2020
    Date of Event
    December 7, 2019
    Report Date
    January 30, 2020
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H6 PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED WITH NO PHYSICAL DAMAGE NOTED. THERE WERE VISUAL INDICATIONS OF PARTICULATES FOUND WITHIN THE CASSETTE COMPARTMENT. A SIMULATED THERAPY WAS INITIATED AND COMPLETED ON THE CYCLER WITHOUT COMPLICATION. THE WEIGHED FILL VOLUMES WERE FOUND TO BE WITHIN TOLERANCE AND FILL TIMES WERE WITHIN SPECIFICATION. THE CYCLER UNDERWENT SYSTEM AIR LEAK AND VALVE ACTUATION TESTING AND WAS FOUND TO MEET PRODUCT SPECIFICATIONS. THE LOAD CELL VERIFICATION FAILED DUE TO STANDOFF SCREWS TOO LOW. ADJUSTED STANDOFF SCREWS TO CONTINUE TESTING AND THE LOAD CELL VERIFICATION 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, THERE WERE NO MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CYCLER PERFORMED AS DESIGNED AND AN ASSOCIATED CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    CLINICAL INVESTIGATION: A TEMPORAL RELATIONSHIP EXISTS BETWEEN CONTINUES CYCLING PERITONEAL DIALYSIS (CCPD) THERAPY UTILIZING THE LIBERTY SELECT CYCLER, AND THE ADVERSE EVENT OF DEATH. THE PATIENTS CAUSE OF THE DEATH UNKNOWN; THEREFORE, CAUSALITY CANNOT BE ESTABLISHED. THE END-STAGE RENAL DISEASE (ESRD) POPULATION CONTINUES TO HAVE SIGNIFICANTLY HIGHER MORTALITY, AND FEWER EXPECTED YEARS OF LIFE WHEN COMPARED TO THE GENERAL POPULATION. BASED ON THE TOTALITY OF THE INFORMATION AVAILABLE, THE LIBERTY SELECT CYCLER CANNOT BE EXCLUDED FROM HAVING A POSSIBLE CAUSAL OR CONTRIBUTORY ROLE IN THE PATIENT¿S DEATH. WHILE NO TREATMENT ALARMS WERE NOTED, THE PATIENT WAS ACTIVELY UNDERGOING CCPD THERAPY VIA THE LIBERTY SELECT CYCLER WHEN HE EXPIRED. THEREFORE, THERE IS INSUFFICIENT EVIDENCE TO DISASSOCIATE THE LIBERTY SELECT CYCLER FROM THE EVENTS. PLANT INVESTIGATION: TO DATE, NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) CONTACT FRESENIUS TECHNICAL SUPPORT REQUESTING A CYCLER BE PICKED UP AT THE CLINIC. IT WAS REPORTED THAT THE PATIENT WAS HOOKED UP TO THE MACHINE WHEN THEY PASSED AWAY. DURING FOLLOW-UP, THE PDRN STATED THE PATIENT PASSED AWAY PEACEFULLY IN THEIR SLEEP ON (B)(6) 2019. THE PATIENT¿S CAUSE OF DEATH IS UNKNOWN, AND PER THE SPOUSE¿S REQUEST, NO AUTOPSY WAS PERFORMED. THE PDRN STATED NO LIBERTY SELECT CYCLER ALARMS WERE NOTED DURING TREATMENT ON (B)(6) 2019, NOR DID THE PATIENT EXPERIENCE ANY TREATMENT ISSUES. ADDITIONAL INFORMATION WAS REQUESTED (E.G. TREATMENT RECORD, DEATH CERTIFICATE, ESRD DEATH NOTIFICATION), HOWEVER THE RECORDS WERE UNAVAILABLE DURING FOLLOW-UP. IT WAS REPORTED THE PATIENT¿S LIBERTY SELECT CYCLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22480 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 180343 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death DELFLEX PD FLUID| LIBERTY CYCLER SET | DELFLEX PD FLUID| LIBERTY CYCLER SET