BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 8642220 · Received May 24, 2019

    Report

    Report Number
    2937457-2019-01667
    Event Type
    Injury
    Date Received
    May 24, 2019
    Date of Event
    April 8, 2019
    Report Date
    August 23, 2019
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CLINICAL REVIEW: A TEMPORAL RELATIONSHIP EXISTS BETWEEN PD THERAPY UTILIZING THE LIBERTY SELECT CYCLER/LIBERTY CYCLER SET AND THE PATIENT¿S PERITONITIS EVENT. HOWEVER, CURRENTLY THERE IS NO OBJECTIVE EVIDENCE THAT A LIBERTY SELECT CYCLER/FMC CASSETTE PRODUCT ISSUE CAUSED OR CONTRIBUTED TO THE EVENT. THE PATIENT¿S STAPHYLOCOCCUS AUREUS PERITONITIS CAN BE REASONABLY ATTRIBUTED TO TOUCH CONTAMINATION. STAPHYLOCOCCUS AUREUS IS A BACTERIUM FOUND ON HUMAN SKIN/NARES AND A WELL-KNOWN SOURCE OF PERITONITIS CAUSED BY TOUCH CONTAMINATION DURING THE PD PROCEDURE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS FOLLOWING TRANSITION TO FRESENIUS PRODUCTS. THE NATURE AND DEGREE OF PATIENT TRAINING AS WELL AS PATIENT UNDERSTANDING AND ADHERENCE TO PROCEDURE IS UNKNOWN. THE PATIENT DOES PERFORM A DAYTIME MANUAL EXCHANGE. A CULTURE TEST WAS PERFORMED, AND THE RESULTS CONFIRMED GROWTH OF STAPHYLOCOCCUS AUREUS. THERE WAS TOUCH CONTAMINATION, HOWEVER THE PATIENT DID REPORT THE EVENT TO THEIR CLINIC FOR TWO DAYS. THE PATIENT WAS TREATED WITH ANTIBIOTICS (TYPE, DOSE, ROUTE, FREQUENCY UNKNOWN). ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER TO DATE HAS NOT BEEN PROVIDED.

    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 WAS DIAGNOSED WITH PERITONITIS. A CULTURE WAS OBTAINED WHICH CONFIRMED THE DIAGNOSIS OF PERITONITIS, HOWEVER THE ORGANISM WAS UNKNOWN. THE CAUSE OF PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH ANTIBIOTICS (TYPE, DOSE, ROUTE, DURATION UNKNOWN). ADDITIONAL INFORMATION HAS BEEN REQUESTED, HOWEVER TO DATE NOT PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE REASSESSED AND UPDATED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435675 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

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