BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 9677733 · Received February 6, 2020

    Report

    Report Number
    2937457-2020-00255
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    January 22, 2020
    Report Date
    February 19, 2020
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    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 · 0

    CORRECTION: A2, H6 THE FDA PATIENT CODE "NO CODE AVAILABLE" HAS BEEN SELECTED TO CAPTURE THE REPORT OF THE PATIENT'S GI BLEED.

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.  CLINICAL INVESTIGATION: A TEMPORAL RELATIONSHIP EXISTS BETWEEN CCPD THERAPY UTILIZING THE LIBERTY SELECT CYCLER AND THE ADVERSE EVENTS OF GI BLEEDING, CHARACTERIZED BY ABDOMINAL PAIN AND CRAMPING, WHICH REQUIRED HOSPITALIZATION AND THE TRANSFUSION OF BLOOD. THE DEFINITIVE CAUSE OF THE EVENT IS UNKNOWN; THEREFORE, CAUSALITY CANNOT BE FIRMLY ESTABLISHED. HOWEVER, GI COMPLICATIONS ARE KNOWN TO COMMONLY OCCUR IN RENAL FAILURE PATIENTS; THE MOST COMMON OF WHICH INCLUDE NAUSEA, VOMITING, ABDOMINAL PAIN, CONSTIPATION, DIARRHEA AND GI BLEEDING. BASED ON THE TOTALITY OF THE INFORMATION AVAILABLE, THE LIBERTY SELECT CYCLER CAN BE DISASSOCIATED FROM THE EVENTS, AS THERE IS NO ALLEGATION OR OBJECTIVE EVIDENCE INDICATING A FRESENIUS PRODUCT DEFICIENCY OR MALFUNCTION WAS ASSOCIATED WITH THE ADVERSE EVENT OR SUBSEQUENT HOSPITALIZATION. FURTHERMORE, THE PATIENT CONTINUES TO UTILIZE THE SAME LIBERTY SELECT CYCLER WITHOUT ANY REPORTED ISSUES OR ALLEGATIONS OF MACHINE MALFUNCTION OR DEFICIENCY.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT CAREGIVER CONTACTED FRESENIUS TECHNICAL SUPPORT REQUESTING ASSISTANCE TO DISCONNECT THE PATIENT DURING THEIR PD TREATMENT. IT WAS REPORTED AN AMBULANCE WAS TAKING THE PATIENT TO THE HOSPITAL. FOLLOW-UP WITH THE PATIENT¿S PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) REVEALED THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2020 THROUGH (B)(6) 2020 FOR ABDOMINAL PAIN AND SEVERE CRAMPING, DUE TO A GASTROINTESTINAL (GI) BLEED. THE PATIENT¿S GI BLEED WAS IDENTIFIED DURING A COLONOSCOPY (SPECIFICS NOT PROVIDED), AND THE PATIENT WAS TRANSFUSED WITH 2 UNITS OF PACKED RED BLOOD CELLS. PER THE PDRN, THE CAUSE OF THE EVENTS IS UNRELATED TO THE UTILIZATION OF THE LIBERTY SELECT CYCLER OR ANY FRESENIUS PRODUCT(S) OR DEVICE(S). THE CAUSE OF THE PATIENT¿S GI BLEED IS UNKNOWN; HOWEVER, THE PATIENT WAS DISCHARGED WITH A GASTROENTEROLOGY APPOINTMENT FOR FURTHER EVALUATION. THE DISCHARGE SUMMARY WAS REQUESTED; HOWEVER, IT WAS UNAVAILABLE DURING THE CALL. THE PATIENT CONTINUED TO UNDERGO CONTINUOUS CYCLIC PERITONEAL DIALYSIS (CCPD) WHILE HOSPITALIZED AND RESUMED CCPD THERAPY AT HOME (AS PROVIDED BY A CAREGIVER), UTILIZING THE SAME LIBERTY SELECT CYCLER AS BEFORE THE EVENTS. THE PDRN REPORTED THE PATIENT HAS RECOVERED FROM THE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139623 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 180343 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R DELFLEX PD FLUID| LIBERTY CYCLER SET