BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED)

    MDR report key: 8615454 · Received May 16, 2019

    Report

    Report Number
    2937457-2019-01512
    Event Type
    Injury
    Date Received
    May 16, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 22, 2019
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861100972
    PMA / PMN Number
    K123630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: 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.

    Additional Manufacturer Narrative · 1

    CLINICAL INVESTIGATION: A TEMPORAL RELATIONSHIP EXISTS BETWEEN CCPD THERAPY UTILIZING THE LIBERTY CYCLER AND THE ADVERSE EVENT OF CHEST PAIN. PER THE PDRN, THE LIBERTY CYCLER FUNCTIONED AS INTENDED, AND THE PROGRAMMED FILL VOLUME ¿STRAINED¿ THE PATIENT¿S HEART WHICH CAUSED THE PATIENT¿S CHEST PAIN. THE FILE CONTAINS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A LIBERTY CYCLER PRODUCT DEFICIENCY OR MALFUNCTION WAS ASSOCIATED WITH THE EVENT. THEREFORE, BASED ON THE INFORMATION AVAILABLE, THE LIBERTY CYCLER IS DISASSOCIATED FROM THE EVENT, AS THERE IS NO OBJECTIVE EVIDENCE THAT A FRESENIUS DEVICE(S) OR PRODUCT(S) CAUSED OR CONTRIBUTED TO THE SERIOUS ADVERSE EVENT. MOREOVER, THE PATIENT CONTINUED TO UTILIZE THE SAME LIBERTY CYCLER WITHOUT ANY REPORTED ISSUES OR ALLEGATIONS OF MACHINE MALFUNCTION OR DEFICIENCY. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS NURSE (PDRN) FOR A PERITONEAL DIALYSIS (PD) PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) CONTACTED TECHNICAL SUPPORT FOR ASSISTANCE AND DURING THE CALL THE PDRN REPORTED THAT THE PATIENT WAS HAVING CHEST PAIN. THE PDRN WANTED TO KNOW IF THE CYCLER WOULD ALLOW THEM TO MAKE A CHANGE TO THE FILL VOLUME WHILE IN TREATMENT. THE PDRN WAS ADVISED TO BYPASS THE PATIENT TO A DWELL IF THEY PREFER NOT FILLING TO THE FULL 2200 ML. UPON FOLLOW-UP, THE PDRN REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR CARDIAC RELATED ISSUES (SPECIFICS NOT PROVIDED), AND A CARDIAC WORK-UP (SPECIFICS NOT PROVIDED). ON (B)(6) 2019 THE PATIENT REPORTED EXPERIENCING CHEST PAIN DURING CCPD THERAPY, HOWEVER THE PDRN REDUCED THE FILL VOLUME FROM 2200 ML TO 1800 ML, WHICH RESOLVED THE PATIENT¿S CHEST PAIN. SINCE THE EVENT, THE PATIENT CONTINUES TO UTILIZE A FILL VOLUME OF 1800 ML, AND HAS NOT EXPERIENCED A RETURN OF SYMPTOMS. PER THE PDRN, THE EVENT WAS UNRELATED TO THE USE OF THE LIBERTY CYCLER. THE PATIENT¿S FILL VOLUME OF 2200 ML REPORTEDLY ¿STRAINED¿ THE PATIENT'S HEART AND CAUSED THE CHEST PAIN. THE PDRN STATED THAT THE PATIENT HAS RECOVERED FROM THE EVENT AND CONTINUES TO PERFORM CCPD WITHOUT ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411376 UL LIBERTY CYCLER ASSEMBLY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861100972

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R DELFLEX PD FLUID| LIBERTY CYCLER SET| DELFLEX PD FLUID| LIBERTY CYCLER SET