BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2243502 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00069
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    November 20, 2010
    Report Date
    August 19, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: THE DHR OF THIS PRODUCT 050-87212 AND LOT 10AR08090 WAS REVIEWED AND THE FOLLOWING WAS FOUND: (B)(4). ALL APPLICABLE TESTS DURING IN-PROCESS AND FINAL INSPECTIONS WERE CONDUCTED IN ORDER TO ENSURE PRODUCT INTEGRITY AND WERE DOCUMENTED WITH ACCEPTABLE RESULTS ACCORDING TO APPLICABLE PROCEDURES. LIBERTY CASSETTE LOT NUMBER: A051001 USED TO PRODUCE CODE 050-87212 LOT NUMBER 10AR08090 WAS REVIEWED AND NO (B)(4). THE COMPLAINT DATABASE WAS CONSULTED HAVING THIS TO CONSIDER: NO OTHER COMPLAINT HAD BEEN RECEIVED WITH THIS SAME FAILURE DESCRIPTION FOR THIS LOT. SAMPLE ANALYSIS: (B)(4) RECEIVED SEVEN COMPANION SAMPLES FROM THIS CODE AND LOT. PERFORMED A VISUAL ANALYSIS TO THE WHOLE SAMPLES AND NO DAMAGE OR DEFECT WAS FOUND. FUNCTIONAL TEST WITH THE LIBERTY CYCLER MACHINE WAS PERFORMED TO WHOLE COMPANION SAMPLES WITH THE FOLLOWING RESULTS: THE CASSETTE COMPANION DID NOT SHOW ANY PROBLEMS AND THE TREATMENTS WERE COMPLETED SUCCESSFULLY WITHOUT ANY LEAKS. CONCLUSION: THE REPORTED COMPLAINT IS NOT CONFIRMED AS THE COMPANION SAMPLES DID NOT SHOW ANY DEFECTS. SINCE THE COMPLAINT WAS NOT CONFIRMED, NO CORRECTIVE ACTION IS DOCUMENTED AT THIS TIME. FMC WILL CONTINUE TO MONITOR AND TREND.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT HAS REPORTED SHE OBSERVED FLUID LEAKING FROM THE CASSETTE. THE LEAK OCCURRED DURING SET UP. THERE WAS NO REPORT OF PATIENT ILL EFFECT. SHE HAS COMPANION SAMPLES FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PATIENT CONNECT PERITONEAL DIALYSIS TUBING TREATMENT SET FKX REYNOSA MANUFACTURING NA 10AR08090

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LIBERTY DIALYSIS MACHINE: