BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 8124187 · Received December 3, 2018

    Report

    Report Number
    2937457-2018-03534
    Event Type
    Malfunction
    Date Received
    December 3, 2018
    Date of Event
    November 14, 2018
    Report Date
    December 26, 2018
    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

    UPDATED 501(K) NUMBER TO K181108. THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGNS OF PHYSICAL DAMAGE. THERE WERE NO INDICATIONS OF DRIED FLUID INSIDE THE CASSETTE COMPARTMENT. NO BURRS OR SHARP EDGES IN CASSETTE AREA THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. THE GO/NO GO GAUGE CHECK PASSED. AN (AS-RECEIVED) SIMULATED TREATMENT WAS PERFORMED AND COMPLETED WITHOUT FAILURES. THE CYCLER WEIGHED FILL VOLUME VALUES WERE WITHIN TOLERANCE FOR A LIBERTY CYCLER. THERE WERE NO FLUID LEAKS IN THE TEST CASSETTE DURING THE TREATMENT TEST. WITH THE COMPLAINT CYCLER ON A LIBERTY CART, THERE WERE NO UNUSUAL NOISES/SOUNDS EMITTED BY THE CYCLER DURING THE TREATMENT TESTS. THE SYSTEM AIR LEAK TEST PASSED. THE VALVE ACTUATION TEST PASSED. THE LOAD CELL VERIFICATION WAS WITHIN TOLERANCE. AN INTERNAL INSPECTION OF THE CYCLER FOUND DRIED FLUID WITHIN THE RECESS OF THE BOTTOM COVER ADJACENT TO THE PUMP. THE CAUSE OF THE ENCOUNTERED DRIED FLUID COULD NOT BE DETERMINED. THE MUSHROOM HEAD CHECK PASSED. THE CYCLER TESTED NEGATIVE FOR GLUCOSE. 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

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED AN INCREASED INTRAPERITONEAL VOLUME (IIPV) EVENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE EVENT WAS DISCOVERED WHILE REVIEWING THE PATIENT¿S TREATMENT RECORDS FOLLOWING A REPORT OF A PATIENT HAVING PATIENT LINE AND DRAIN LINE ALARMS. AS A RESULT OF THE IIPV EVENT, THE TECHNICAL SUPPORT REPRESENTATIVE ADVISED THE PATIENT TO DISCONTINUE USE OF THE CYCLER AND TO NOTIFY THEIR PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) OF THE EVENT. UPON FOLLOW UP WITH THE PDRN, IT WAS CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PDRN STATED THAT THE PATIENT IS TRAINED ON PERFORMING STAT DRAINS, AS WELL AS MANUAL PERITONEAL DIALYSIS THERAPY IF NEEDED, AND STATED THE PATIENT WAS ABLE TO DRAIN MANUALLY AT THE END OF TREATMENT. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND CONTINUING WITH PD THERAPY WITHOUT ISSUE. THE CYCLER WAS REPORTED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    966837 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR DELFLEX PD FLUID| LIBERTY CYCLER SET| DELFLEX PD FLUID| LIBERTY CYCLER SET