BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 20698858 · Received November 15, 2024

    Report

    Report Number
    0008030665-2024-01076
    Event Type
    Death
    Date Received
    November 15, 2024
    Date of Event
    November 5, 2024
    Report Date
    January 27, 2025
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY. CLINICAL REVIEW: BASED ON THE LIMITED INFORMATION AVAILABLE, THE PATIENT¿S LIBERTY SELECT CYCLER CANNOT BE DISASSOCIATED FROM THE SERIOUS ADVERSE EVENTS. THERE IS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A FRESENIUS DEVICE(S) AND/OR PRODUCT(S) CAUSED AND/OR CONTRIBUTED TO THE SERIOUS ADVERSE EVENT. HOWEVER, GIVEN THE LACK OF CLINICAL FOLLOW-UP, MEDICAL HISTORY, TREATMENT RECORDS, AND NO MANUFACTURER EVALUATION OF THE SUSPECT DEVICE; THIS LIBERTY SELECT CYCLER CANNOT BE EXCLUDED FROM HAVING A POSSIBLE CAUSAL OR CONTRIBUTORY ROLE IN THE SERIOUS ADVERSE EVENT EXPERIENCED BY THE PATIENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION PROVIDED IN D9 AND H3. PLANT INVESTIGATION: A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGNS OF PHYSICAL DAMAGE. THERE WERE VISUAL INDICATIONS OF DRIED FLUID WITHIN THE CASSETTE COMPARTMENT ON THE PUMP. THERE WERE NO VISUAL INDICATIONS OF PARTICULATES WITHIN THE CASSETTE AREA. THERE WERE NO BURRS OR SHARP EDGES IN CASSETTE AREA THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. A SIMULATED TREATMENT USING (AS-RECEIVED) TREATMENT SETTINGS WITH REDUCED DWELL TIMES WAS PERFORMED AND COMPLETED WITHOUT ANY FAILURES OR PROBLEMS. NO FLUID LEAKS IN THE TEST CASSETTE DURING THE TREATMENT TEST. SYSTEM AIR LEAK TEST PASSED. TEACH PUMP TEST PASSED. VALVE ACTUATION TEST PASSED. AN INTERNAL VISUAL OF THE RETURNED CYCLER WAS PERFORMED. THERE WERE VISUAL INDICATIONS OF DRIED FLUID ON THE BOTTOM COVER BEHIND THE FRONT PANEL ASSEMBLY. THE CAUSE OF THE OBSERVED DRIED FLUID COULD NOT BE DETERMINED. THERE WERE NO DISCREPANCIES ENCOUNTERED WITH THE MUSHROOM HEADS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER FOR RENAL REPLACEMENT THERAPY (RRT) EXPIRED WHILE HOSPITALIZED ON (B)(6) 2024. DURING INTAKE, THE PATIENT¿S PD REGISTERED NURSE (PDRN) REPORTED THE CAUSE OF DEATH WAS UNKNOWN. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION (E.G., PATIENT DEMOGRAPHICS, DISCHARGE SUMMARY, ESRD DEATH NOTIFICATION, DEATH CERTIFICATE, TREATMENT RECORDS) WERE UNSUCCESSFUL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [CC(PD)] UTILIZING A LIBERTY SELECT CYCLER FOR RENAL REPLACEMENT THERAPY (RRT) EXPIRED WHILE HOSPITALIZED ON (B)(6)2024. DURING INTAKE, THE PATIENT¿S PD REGISTERED NURSE (PDRN) REPORTED THE CAUSE OF DEATH WAS UNKNOWN. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL CLINICAL INFORMATION (E.G., PATIENT DEMOGRAPHICS, DISCHARGE SUMMARY, ESRD DEATH NOTIFICATION, DEATH CERTIFICATE, TREATMENT RECORDS) WERE UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43539 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX ERIKA DE REYNOSA, S.A. DE C.V. 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| D DELFLEX PD FLUID.| DELFLEX PD FLUID.| LIBERTY CYCLER SET.| LIBERTY CYCLER SET.