BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 12019830 · Received June 17, 2021

    Report

    Report Number
    2937457-2021-01274
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 31, 2021
    Report Date
    July 7, 2021
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861102068
    PMA / PMN Number
    K181108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION:D9, H3 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. THERE WERE VISUAL INDICATIONS OF FLUID FOUND WITHIN THE CASSETTE COMPARTMENT. THERE WERE NO VISUAL INDICATIONS OF PARTICULATES FOUND WITHIN THE CASSETTE COMPARTMENT. THERE WERE NO BURRS OR SHARP EDGES IN CASSETTE COMPARTMENT THAT MAY HAVE PUNCTURED A CASSETTE MEMBRANE. THE SIMULATED TREATMENT POST-ACCELERATED STRESS TEST 2-HOUR 15-MINUTE 8500 ML TEST PASSED. NO FLUID LEAKS WERE FOUND DURING THE REMOVAL OF THE CASSETTE. THE CYCLER UNDERWENT AND PASSED A PATIENT SENSOR CALIBRATION CHECK. AN INVESTIGATION OF THE CYCLER MUSHROOM HEADS VERIFIED THAT THE SURFACE CONDITIONS AND ALIGNMENTS WERE WITHIN SPECIFICATION. AN INTERNAL VISUAL INSPECTION IDENTIFIED EVIDENCE OF DRIED FLUID WITHIN THE RECESS OF THE BOTTOM COVER ADJACENT TO THE PUMP AND THE FILTERS. THE CAUSE OF THE ENCOUNTERED DRIED 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 FOUND THAT THE FLUID LEAK BOX HAD BEEN CHECKED ON THE CYCLER IDENTIFYING, DISINFECTING, AND DISPOSITION FORM. THE MUSHROOM HEAD CHECK HAD PREVIOUSLY PASSED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT DISCOVERED A FLUID LEAK FROM THE CASSETTE DURING STEP 9 OF THEIR PD TREATMENT. THE PATIENT CONTACT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 2 OF 4 OF TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT CONTACT WAS ADVISED TO DISCONTINUE THE USE OF THE CYCLER AND FOLLOW UP WITH THE PATIENT¿S PERITONEAL DIALYSIS NURSE (PDRN). A NEW CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT CONTACT 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 PERITONEAL DIALYSIS TREATMENT USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) IN THE ABSENCE OF THE CYCLER. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT CONTACT STATED THAT THE FLUID LEK ORIGINATED FROM THE CASSETTE. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE LIBERTY CYCLER SET 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.

    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 FROM THE CASSETTE DURING STEP 9 OF THEIR PD TREATMENT. THE PATIENT CONTACT REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 2 OF 4 OF TREATMENT. IT IS UNKNOWN AT WHICH POINT IN THERAPY THE LEAK MAY HAVE BEGUN. THE CAUSE OF THE LEAK IS UNKNOWN. THE PATIENT CONTACT WAS ADVISED TO DISCONTINUE THE USE OF THE CYCLER AND FOLLOW UP WITH THE PATIENT¿S PERITONEAL DIALYSIS NURSE (PDRN). A NEW CYCLER WAS ISSUED TO THE PATIENT. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PATIENT CONTACT 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 PERITONEAL DIALYSIS TREATMENT USING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) IN THE ABSENCE OF THE CYCLER. THE PATIENT DID NOT DEVELOP ANY SYMPTOMS, ADVERSE EVENTS, INJURIES, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. THE PATIENT CONTACT STATED THAT THE FLUID LEK ORIGINATED FROM THE CASSETTE. THE PATIENT HAS RECEIVED A NEW CYCLER WHICH IS WORKING WELL AND IS CONTINUING PERITONEAL DIALYSIS THERAPY WITH NO FURTHER ISSUES. THE LIBERTY CYCLER SET 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
    912683 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 180343 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR DELFLEX PD FLUID| DELFLEX PD FLUID| LIBERTY CYCLER SET | LIBERTY CYCLER SET