BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2243530 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00068
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    November 18, 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 10HR08038 WAS REVIEWED AND THE FOLLOWING WAS FOUND: THE ASSEMBLY OF THIS PRODUCT DID NOT HAVE ANY NCR OR DEVIATIONS DOCUMENTED DURING MANUFACTURING PROCESS. 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: 10ER0741 USED TO PRODUCE CODE 050-87212 LOT NUMBER 10HR08038 WAS REVIEWED AND NO ISSUES WERE REPORTED DURING THE MANUFACTURING PROCESS. 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: THE ACTUAL SAMPLE AS WELL AS COMPANION SAMPLES WERE RECEIVED. A VISUAL ANALYSIS WAS PERFORMED TO SAMPLES AND NO DAMAGE OR DEFECTS WERE FOUND. FUNCTIONAL TESTS WITH LIBERTY CYCLER MACHINE WAS PERFORMED TO BOTH THE ACTUAL AND COMPANION SAMPLES WITH THE FOLLOWING RESULTS: THE COMPANION CASSETTES AND ACTUAL SAMPLE DID NOT SHOW ANY PROBLEMS, THE TREATMENTS WERE SUCCESSFULLY COMPLETED WITHOUT ANY LEAKS. CONCLUSION: THE ACTUAL AND COMPANION SAMPLES DID NOT SHOW ANY DEFECTS. THE COMPLAINT IS DEEMED AS NOT CONFIRMED. SINCE THE COMPLAINT WAS NOT CONFIRMED NO CORRECTIVE ACTION IS DOCUMENTED AT THIS TIME. FMC WILL CONTINUE MONITORING THIS TYPE OF DEFECT PER CURRENT PROCEDURE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REPORTED THAT THE CASSETTE LEAKED INTO THE CYCLER CASSETTE COMPARTMENT. THERE IS NO REPORT OF PATIENT ILL EFFECT. THE SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PATIENT CONNECT PERITONEAL DIALYSIS TREATMENT SET FKX REYNOSA MANUFACTURING NA 10HR08038

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LIBERTY DIALYSIS MACHINE: