BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 8151330 · Received December 11, 2018

    Report

    Report Number
    2937457-2018-03638
    Event Type
    Malfunction
    Date Received
    December 11, 2018
    Date of Event
    November 25, 2018
    Report Date
    January 3, 2019
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: 510K# UPDATED 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. THE AST TEST WAS PERFORMED AND PASSED. NO FLUID LEAKS IN THE TEST CASSETTE DURING THE ACCELERATED STRESS TEST. 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

    A PERITONEAL DIALYSIS (PD) PATIENT REPORTED FINDING FLUID LEAKS IN THE CASSETTE DOOR OF THEIR FRESENIUS LIBERTY SELECT CYCLER AT THE END OF THEIR (B)(6) 2018 PD TREATMENT. THE CYCLER SOUNDED THE AIR DETECTED IN CASSETTE MESSAGE DURING FILL 3 OF THE PATIENT¿S TREATMENT, AFTER WHICH THE PATIENT CANCELLED THEIR TREATMENT AND FOUND THE FLUID LEAKS. THE PATIENT ADVISED THEY WOULD COMPLETE THEIR TREATMENT VIA MANUAL THERAPY. A REPLACEMENT CYCLER WAS SHIPPED TO THE PATIENT, AND THE ORIGINAL CYCLER WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. DUE DILIGENCE ATTEMPTS WERE EXHAUSTED, BUT NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991574 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

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