BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 6505366 · Received April 19, 2017

    Report

    Report Number
    2937457-2017-00270
    Event Type
    Injury
    Date Received
    April 19, 2017
    Date of Event
    March 20, 2017
    Report Date
    June 8, 2017
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K123630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER. A VISUAL INSPECTION OF THE RETURNED CYCLER EXTERIOR SHOWED NO SIGN OF PHYSICAL DAMAGE. A SIMULATED TREATMENT WAS PERFORMED AND COMPLETED WITHOUT ANY FAILURES OR PROBLEMS. THE CYCLER PROGRAMMED DISPLAYED FILL AND DRAIN VOLUME VALUES WERE WITHIN THE TOLERANCES. AT THE END OF THE SIMULATED TREATMENT THE TEST CASSETTE WAS REMOVED AND THE CYCLER WAS POWERED DOWN FOR APPROXIMATELY 1 MINUTE AND THEN POWERED ON. DURING THE START-UP PROCESS A ¿MWD WATCHDOG TIMER ERROR ALARM¿ OCCURRED AND THE CYCLER WAS POWERED DOWN. THE CYCLER WEIGHED FILL VOLUME VALUES WERE WITHIN TOLERANCE AND CYCLER PROGRAMMED DISPLAYED FILL AND DRAIN VOLUME VALUES WERE WITHIN THE TOLERANCES. THE VALVE ACTUATION TEST PASSED. THE SYSTEM AIR LEAK TEST PASSED. THE PATIENT SENSOR CALIBRATION CHECK PASSED. THE LOAD CELL VERIFICATION WAS WITHIN TOLERANCE. INSTALLED A KNOWN GOOD FUNCTION BOARD AND ANOTHER SIMULATED TREATMENT WAS PERFORMED AND COMPLETED WITHOUT ANY FAILURES OR PROBLEMS. DURING THE START-UP PROCESS THE ¿MWD WATCHDOG TIMER ERROR ALARM¿ DID NOT OCCUR. THERE WERE NO DISCREPANCIES ENCOUNTERED IN THE INTERNAL INSPECTION OF THE CYCLER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE DEVICE MANUFACTURING REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION. ALTHOUGH A TEMPORAL ASSOCIATION BETWEEN THE LIBERTY CYCLER AND THE EVENT OF PERITONITIS EXIST. THERE IS NO DOCUMENTATION THAT SHOWS A CAUSAL RELATIONSHIP BETWEEN THE EVENT OF PERITONITIS AND THE LIBERTY CYCLER. ADDITIONALLY, THERE IS NO ALLEGATION AGAINST ANY FRESENIUS PRODUCTS AND THE ADVERSE EVENT OF PERITONITIS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REPORTED THAT SHE WAS HAVING ABDOMINAL PAIN DURING TREATMENT. SHE REPORTED SHE HAD BEEN SEEN IN THE CLINIC AND TOLD THAT SHE HAD PERITONITIS. THE PATIENT REPORTED THAT SHE WAS BEING TREATED WITH VANCOMYCIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287033 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention DEFLEX PD SOLUTION