BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 8621280 · Received May 17, 2019

    Report

    Report Number
    2937457-2019-01547
    Event Type
    Injury
    Date Received
    May 17, 2019
    Date of Event
    May 6, 2019
    Report Date
    May 17, 2019
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    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-CONFORMANCE, 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. CLINICAL REVIEW: THERE IS A TEMPORAL RELATIONSHIP BETWEEN PD THERAPY ON THE LIBERTY SELECT CYCLER WITH CYCLER SET AND THE PATIENT EVENT OF ABDOMINAL PAIN WITH DIAGNOSIS OF PERITONITIS. HOWEVER, THERE IS NO DOCUMENTATION IN THE COMPLAINT THAT SHOWS A CAUSAL RELATIONSHIP BETWEEN THE EVENT AND THE LIBERTY SELECT CYCLER AND CYCLER SET. ADDITIONALLY, THERE IS NO ALLEGATION OF A MACHINE MALFUNCTION OR DEFICIENCY OR A REPORTED LEAK WITH THE CYCLER SET. ALTHOUGH A CAUSE OF THE PERITONITIS CANNOT BE DETERMINED IT IS UNLIKELY THAT THE LIBERTY SELECT CYCLER OR CYCLER SET WAS THE CAUSE BASED ON THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    A PATIENT ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) FOR RENAL REPLACEMENT THERAPY (RRT) CONTACTED TECHNICAL SUPPORT FOR A PATIENT LINE BLOCKED ALARM. DURING THE CALL THE PATIENT REPORTED THAT THEY WERE BEING TREATED WITH ANTIBIOTICS DUE TO PERITONITIS THAT THEY GOT THE PREVIOUS NIGHT. ADDITIONAL INFORMATION WAS OBTAINED WITH THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). THE PDRN STATED THE PATIENT BEGAN EXPERIENCING ABDOMINAL PAIN AND SUBSEQUENTLY WAS SEEN AT THE PD CLINIC AND DIAGNOSED WITH PERITONITIS BASED ON THE ABDOMINAL PAIN AND THE PD EFFLUENT BEING CLOUDY. PD EFFLUENT CULTURES WERE DRAWN AND THE PATIENT WAS INITIATED ON ANTIBIOTIC THERAPY. THE PATIENT WAS PRESCRIBED INTRAPERITONEAL (IP) VANCOMYCIN EVERY 5 DAYS AND CEFTAZIDIME ONCE DAILY (DOSE AND DURATION UNKNOWN). THE CULTURE RESULTS WERE STILL PENDING. THE PATIENT DID NOT REPORT ANY LEAK WITH THE LIBERTY CYCLER SET OR ANY ISSUES WITH THE LIBERTY SELECT CYCLER FOR THIS EVENT. THE CAUSE OF THE PERITONITIS HAS NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413821 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention DELFLEX PD FLUID| LIBERTY CYCLER SET