BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 15640132 · Received October 20, 2022

    Report

    Report Number
    0002937457-2022-01760
    Event Type
    Malfunction
    Date Received
    October 20, 2022
    Date of Event
    October 5, 2022
    Report Date
    December 21, 2022
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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

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

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT'S CARETAKER REPORTED THAT A PATIENT ENCOUNTERED A FLUID LEAK DURING PD TREATMENT. DURING DRAIN 1 OF 5 THERE WAS A WARNING OF AIR DETECTED IN CASSETTE. FLUID WAS DISCOVERED IN THE PUMP MODULE AREA AND ON EXTERNAL PART OF CASSETTE. IN A FOLLOW UP, THE CARETAKER CONFIRMED THE REPORTED EVENT AND STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE CARETAKER CONFIRMED THAT THE PATIENT HAS RECEIVED A REPLACEMENT CYCLER AND IS CONTINUING WITH PERITONEAL DIALYSIS ON THE NEW CYCLER WITHOUT ISSUE. THE CYCLER IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 0

    A PERITONEAL DIALYSIS (PD) PATIENT'S CARETAKER REPORTED THAT A PATIENT ENCOUNTERED A FLUID LEAK DURING PD TREATMENT. DURING DRAIN 1 OF 5 THERE WAS A WARNING OF AIR DETECTED IN CASSETTE. FLUID WAS DISCOVERED IN THE PUMP MODULE AREA AND ON EXTERNAL PART OF CASSETTE. IN A FOLLOW UP, THE CARETAKER CONFIRMED THE REPORTED EVENT AND STATED THAT THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE CARETAKER CONFIRMED THAT THE PATIENT HAS RECEIVED A REPLACEMENT CYCLER AND IS CONTINUING WITH PERITONEAL DIALYSIS ON THE NEW CYCLER WITHOUT ISSUE. THE CYCLER IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2821172 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 180343 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY CYCLER SET| LIBERTY CYCLER SET