BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT.DL

    MDR report key: 2243523 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00061
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    January 15, 2011
    Report Date
    August 9, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: THE DHR FOR THIS PRODUCT AND LOT WAS REVIEWED AND THE FOLLOWING WAS FOUND: THE ASSEMBLY OF THIS PRODUCT DID NOT HAVE ANY NCR OR DEVIATIONS DOCUMENTED DURING THE MFG PROCESS. ALL THE APPLICABLE TESTS DURING THE IN PROCESS AND FINAL INSPECTIONS WERE CONDUCTED IN ORDER TO ENSURE PRODUCT INTEGRITY AND DOCUMENTED WITH ACCEPTABLE RESULTS ACCORDING TO APPLICABLE PROCEDURES. LIBERTY CASSETTE LOT NUMBER: L291003 USED TO PRODUCE CODE 050-87216 LOT NUMBER 10NR08087 WAS REVIEWED AND NO ISSUES WERE REPORTED DURING INCOMING INSPECTION. SAMPLE ANALYSIS: THE MFG FACILITY RECEIVED THE ACTUAL SAMPLE AND PERFORMED A VISUAL ANALYSIS AND NO DAMAGE OR DEFECTS WERE FOUND. A FUNCTIONAL TEST WITH THE LIBERTY CYCLER MACHINE WAS PERFORMED TO THE ACTUAL SAMPLE WITH THE FOLLOWING RESULTS: THE TUBING SET DID NOT SHOW ANY PROBLEMS, THE TREATMENT WAS COMPLETED SUCCESSFULLY WITHOUT ANY LEAKS. CONCLUSION: THE ACTUAL SAMPLE DID NOT SHOW ANY DEFECTS. THE COMPLAINT IS DEEMED AS NOT CONFIRMED. NO CORRECTIVE ACTION IS DOCUMENTED AT THIS TIME. FCM WILL CONTINUE MONITORING THIS TYPE OF INCIDENT PER CURRENT PROCEDURES.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT REPORTED THAT THE CASSETTE LEAKED INSIDE THE CYCLER. THERE IS NO REPORT OF PT ILL EFFECT. THE SAMPLE IS AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, SINGLE CONN./EXT.DL PERITONEAL DIALYSIS TUBING SET FKX REYNOSA MANUFACTURING NA 10NR08087

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LIBERTY DIALYSIS MACHINE