BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER UL

    MDR report key: 15789536 · Received November 14, 2022

    Report

    Report Number
    0002937457-2022-01960
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    January 1, 2021
    Report Date
    November 14, 2022
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K123630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE SERIAL NUMBER COULD NOT BE OBTAINED. AS A SERIAL NUMBER COULD NOT BE DETERMINED, DEVICE HISTORY AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED. CLINICAL REVIEW: A PROBABLE TEMPORAL RELATIONSHIP EXISTS BETWEEN CCPD THERAPY UTILIZING THE UNKNOWN LIBERTY CYCLER AND THE ADVERSE EVENT(S) OF LOSS OF CONSCIOUSNESS AND FRACTURING/BRUISING RIB(S). THE ETIOLOGY OF THE EVENTS IS UNKNOWN; THEREFORE, CAUSALITY CANNOT BE FIRMLY ESTABLISHED. FURTHERMORE, LIMITED INFORMATION PREVENTED A MORE IN-DEPTH INVESTIGATION AND ROOT CAUSE ANALYSIS. BASED ON THE TOTALITY OF THE INFORMATION AVAILABLE, THE UNKNOWN LIBERTY CYCLER CANNOT BE EXCLUDED FROM HAVING A POSSIBLE CAUSAL OR CONTRIBUTORY ROLE IN THE PATIENT¿S SERIOUS ADVERSE EVENTS. THERE IS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A FRESENIUS DEVICE(S) AND/OR PRODUCT(S) DEFICIENCY OR MALFUNCTION CAUSED OR CONTRIBUTED TO THE EVENTS. HOWEVER, GIVEN THE STATEMENTS MADE BY THE PATIENT, NO AVAILABLE MANUFACTURER EVALUATION OF THE SUSPECT DEVICE(S)/PRODUCT(S), AND/OR LACK OF CAUSALITY, THE DEVICE(S)/PRODUCT(S) CANNOT BE DISASSOCIATED FROM THE SERIOUS ADVERSE EVENTS.

    Description of Event or Problem · 0

    ON 13/NOV/2021, FRESENIUS BECAME AWARE (VIA A CUSTOMER EXPERIENCE SURVEY) THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) PREVIOUSLY ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS [(PD)RN FOR RENAL REPLACEMENT THERAPY (RRT) REPORTEDLY SUFFERED ¿CONSTANT BLACKOUTS¿ (LOSS OF CONSCIOUSNESS), PUSHING MEDICATIONS AND TOTAL FAILURE OF TREATMENT. IT WAS ALSO REPORTED THAT TREATMENT WAS SUPPOSED TO BE TEN HOURS WHEN HE SLEPT BUT TURNED INTO AN ALL DAY NIGHTMARE WITH THE PATIENT NOT ABLE TO SLEEP. SUBSEQUENT ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION (E.G., TIMELINE, INJURIES, DEMOGRAPHIC INFORMATION, CAUSALITY) HAVE THUS FAR PROVEN UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351332 LIBERTY CYCLER UL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING

    Patients

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