BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER UL

    MDR report key: 15816692 · Received November 17, 2022

    Report

    Report Number
    0002937457-2022-01990
    Event Type
    Injury
    Date Received
    November 17, 2022
    Date of Event
    March 1, 2021
    Report Date
    November 17, 2022
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K123630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL REVIEW: THERE IS A TEMPORAL RELATIONSHIP BETWEEN PERITONEAL DIALYSIS THERAPY UTILIZING AN UNKNOWN LIBERTY CYCLER WITH UNKNOWN CASSETTE AND THE PATIENT EVENT OF PERITONITIS AND HOSPITALIZATION WITH SUBSEQUENT TRANSITION TO HEMODIALYSIS. HOWEVER, THERE IS NO DOCUMENTATION IN THE COMPLAINT FILE TO SHOW A CAUSAL RELATIONSHIP BETWEEN THE ADVERSE EVENT AND USE OF THE UNKNOWN LIBERTY CYCLER WITH UNKNOWN CASSETTE. ADDITIONALLY, THERE IS NO ALLEGATION OF A DEVICE MALFUNCTION OR DEFICIENCY, OR CASSETTE DEFECT REPORTED FOR THE EVENT. ALTHOUGH NO INFORMATION WAS OBTAINED RELATED TO CULTURE RESULTS OR THE DETERMINED CAUSE OF THE PERITONITIS, ALL PD PATIENTS ARE AT RISK OF PERITONITIS DUE TO A COMPROMISED IMMUNE SYSTEM AND THE INCREASE OF POTENTIAL FOR MICROBIAL CONTAMINATION FROM DIALYSIS TECHNIQUES. MOST CASES OF PERITONITIS ARE CAUSED BY TOUCH CONTAMINATION BY THE PATIENT WITH THE PD CATHETER BEING A SOURCE OF ENTRY FOR ORGANISMS INTO THE PERITONEUM. THE UNKNOWN CASSETTE CAN BE EXCLUDED AS THE CAUSE OF THE PATIENT¿S REPORTED PERITONITIS EVENT. 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.

    Description of Event or Problem · 0

    DURING A VOICE OF THE CUSTOMER SURVEY, THIS MALE PATIENT WAS ASKED WHY PERITONEAL DIALYSIS (PD) WAS DISCONTINUED. THE PATIENT STATED THEY RECENTLY HAD A SERIOUS INFECTION AND WAS HOSPITALIZED. ADDITIONAL INFORMATION WAS OBTAINED THROUGH FOLLOW-UP WITH THE CLINIC. THE PATIENT WAS DIAGNOSED WITH PERITONITIS IN (B)(6) 2021 (DATE UNKNOWN) AND HOSPITALIZED. THE PATIENT WAS INITIALLY PLACED ON BACK-UP HEMODIALYSIS (HD) DURING RECOVERY. THE PATIENT AND HIS SPOUSE DECIDED NOT TO CONTINUE WITH PD AND TRANSITIONED PERMANENTLY TO IN-CENTER HD. THE PATIENT REMAINS ON HD TODAY. NO FURTHER INFORMATION RELATED TO THE PERITONITIS EVENT WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2829128 LIBERTY CYCLER UL SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Male Hospitalization| R DELFLEX PD FLUID| LIBERTY CYCLER SET