BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 8141246 · Received December 7, 2018

    Report

    Report Number
    2937457-2018-03609
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 24, 2018
    Report Date
    December 19, 2018
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED 501(K) TO K181108 PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AN EXTERNAL VISUAL INSPECTION WAS PERFORMED ON THE CYCLER WITH NO PHYSICAL DAMAGE NOTED. ALTHOUGH THERE WAS EVIDENCE OF DRIED FLUID PRESENT WITHIN THE CASSETTE COMPARTMENT, THERE WERE NO BURRS OR SHARP EDGES IN THE CASSETTE AREA THAT COULD HAVE PUNCTURED THE CASSETTE MEMBRANE. AN AST TEST WAS PERFORMED AND PASSED. NO FLUID LEAKS IN THE TEST CASSETTE DURING THE ACCELERATED STRESS TEST. THE POST-AST TWO HOURS AND FIFTEEN MINUTE 8500 ML SIMULATED TREATMENT WAS PERFORMED AND COMPLETELY WITHOUT FAILURES. THE SYSTEM AIR LEAK TEST PASSED. THE VALVE ACTUATION TEST PASSED. THE PATIENT SENSOR CALIBRATION CHECK PASSED. THE MUSHROOM HEAD CHECK PASSED. THE CYCLER TESTED POSITIVE FOR GLUCOSE. AN INTERNAL VISUAL INSPECTION OF THE CYCLER FOUND VISUAL EVIDENCE OF DRIED FLUID UNDER PUMP ¿A¿ AND ¿B¿ MUSHROOM HEAD AND WITHIN THE RECESS OF THE BOTTOM COVER ADJACENT TO THE PUMP. THE CAUSE OF THE OBSERVED DRIED FLUID AND FLUID COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND VERIFIED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. UPON COMPLETION OF THE EVALUATION, THERE WERE NO MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CYCLER PERFORMED AS DESIGNED AND AN ASSOCIATED CAUSE COULD NOT BE DETERMINED.

    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 DISCOVERED A FLUID LEAK ON THE INSIDE OF THE CASSETTE DOOR OF THEIR CYCLER AFTER ENDING THEIR (B)(6) 2018, PD TREATMENT. THE PATIENT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING TREATMENT. THE ALARM WAS UNABLE TO BE CLEARED AND THE TREATMENT WAS CANCELLED. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER. UPON FOLLOW-UP, THE PERITONEAL DIALYSIS NURSE (PDRN) STATED THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND CONFIRMED THAT THE PATIENT WAS ABLE TO COMPLETE THE PERITONEAL DIALYSIS TREATMENT USING 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 HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE CASSETTE USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER. THE CYCLER WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981953 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR DELFLEX PD FLUID| LIBERTY CYCLER SET| DELFLEX PD FLUID| LIBERTY CYCLER SET