BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY SELECT CYCLER ASSY(NON-VALUATED)

    MDR report key: 8649345 · Received May 29, 2019

    Report

    Report Number
    2937457-2019-01705
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Date of Event
    May 20, 2019
    Report Date
    June 30, 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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE REPORTED SYMPTOMS OF FLUID LEAK AND AIR DETECTED IN CASSETTE WERE NOT CONFIRMED. THERE WERE NO VISUAL INDICATION OF PARTICULATES WITHIN THE CASSETTE AREA. 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 ACCELERATED STRESS TEST (AST) WAS PERFORMED ON THE CYCLER AND PASSED. THERE WERE NO FLUID LEAKS IN THE TEST CASSETTE DURING THE ACCELERATED STRESS TEST. 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. THE CYCLER TESTED POSITIVE FOR GLUCOSE. AN INTERNAL VISUAL INSPECTION IDENTIFIED EVIDENCE OF DRIED FLUID BENEATH THE MUSHROOM HEADS OF PUMP A AND B AND WITHIN THE RECESS OF THE BOTTOM COVER ADJACENT TO THE PUMP. THE CAUSE OF THE 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 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 · 0

    CORRECTION: SHOULD BE K181108.

    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 NURSE (PDRN) REPORTED THAT A FLUID LEAK WAS DISCOVERED ON THE INSIDE OF THE CASSETTE DOOR OF THEIR CYCLER DURING A PATIENT'S PD TREATMENT. THE PDRN REPORTED RECEIVING AN AIR DETECTED IN CASSETTE ALARM DURING DRAIN 2 OF 4 OF TREATMENT 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 PDRN WAS ADVISED TO DISCONTINUE THE USE OF THEIR CYCLER. A NEW CYCLER WAS ISSUED TO THE CLINIC. IT WAS REPORTED THAT AN ALTERNATE TREATMENT OPTION WAS AVAILABLE. UPON FOLLOW UP, THE PDRN STATED THEY WERE 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 PDRN DID NOT KNOW IF THE NEW CYCLER WAS RECEIVED INTO THE CLINIC BUT CONFIRMED THAT THE CASSETTE USED BY THE PATIENT WAS DISCARDED AND IS NOT AVAILABLE FOR RETURN FOR PHYSICAL EVALUATION BY THE MANUFACTURER. THE CYCLER WAS SCHEDULED TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443997 LIBERTY SELECT CYCLER ASSY(NON-VALUATED) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861102068

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR DELFLEX PD FLUID| LIBERTY CYCLER SET| DELFLEX PD FLUID| LIBERTY CYCLER SET