BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 10551647 · Received September 17, 2020

    Report

    Report Number
    2937457-2020-01687
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    September 2, 2020
    Report Date
    February 1, 2021
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: G5- K181108 (TRANSCRIPTION ERROR).

    Additional Manufacturer Narrative · 0

    PLANT INVESTIGATION: A PHYSICAL EVALUATION WILL NOT BE PERFORMED FOR THIS COMPLAINT INVESTIGATION BECAUSE THE PATIENT CONTINUED TO USE THE CYCLER FOR MONTHS AFTER THE CYCLER WAS SCHEDULED TO BE RETURNED AND THE CYCLER IS NO LONGER IN THE CONDITION IN WHICH IT WAS WHEN THE PATIENT EXPERIENCED THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 1

    THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT ENCOUNTERED A FLUID LEAK WITHIN THE CYCLER'S CASSETTE COMPARTMENT WHEN REMOVING THE CASSETTE AFTER CANCELING PD TREATMENT. THE TREATMENT WAS CANCELLED DUE TO RECEIVING AN M31 AIR DETECTED IN CASSETTE ALARM DURING DRAIN 4. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE SOURCE OF THE LEAK IS UNKNOWN. IT WAS REPORTED THAT THERE WAS FLUID WITHIN THE CYCLER. THE PATIENT'S CONTACT WAS ADVISED TO DISCONTINUE THE USE OF THE CYCLER AND FOLLOW UP WITH THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN). A NEW CYCLER WAS ISSUED TO THE CUSTOMER AND THE REPORTED CYCLER WAS SCHEDULED TO BE PICKED UP AND RETURNED FOR PHYSICAL EVALUATION. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PDRN REPORTED THAT TREATMENT WAS COMPLETED WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS TREATED WITH PROPHYLACTIC ANTIBIOTICS VANCOMYCIN 1.5G AND CEFTAZIDIME 1.5G VIA INTRAPERITONEAL ADMINISTRATION. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THERE WAS NO DAMAGE OBSERVED ON THE CYCLER SET AND THERE WAS NO FLUID LEAK OBSERVED FROM THE SOLUTION BAG. THE CASSETTE USED BY THE CUSTOMER IS AVAILABLE. THE PDRN WAS INFORMED A SAMPLE RETURN KIT WOULD BE SHIPPED SO THEY CAN RETURN THE SAMPLE. THE REPORTED CYCLER HAS BEEN RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1015945 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 180343 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR DELFLEX PD FLUID| LIBERTY CYCLER SET| DELFLEX PD FLUID| LIBERTY CYCLER SET