BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2243498 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00062
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    November 16, 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
    SC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: THE DHR WAS REVIEWED AND THE FOLLOWING WAS FOUND: THE ASSEMBLY OF THIS PRODUCT DID NOT HAVE ANY NCR'S OR DEVIATIONS DOCUMENTED DURING THE MANUFACTURING PROCESS RELATED TO THIS FAILURE MODE. ALL APPLICABLE TESTS DURING THE IN-PROCESS AND FINAL INSPECTIONS WERE CONDUCTED IN ORDER TO ENSURE PRODUCT INTEGRITY AND WERE DOCUMENTED WITH ACCEPTABLE RESULTS ACCORDING TO APPLICABLE PROCEDURE. CASSETTE LOT NUMBER USED ARE H091009, H071002 FOR THIS LOTS THERE ARE NOT ANY ISSUES REPORTED DURING PROCESSES. NO OTHER COMPLAINT HAS BEEN RECEIVED WITH SAME FAILURE MODE DESCRIPTION FOR THIS LOT OF 10HR08089. IN-PROCESS INVESTIGATION: THE LIBERTY CYCLER PROCESS WAS INVESTIGATED TO DETECT ANY POTENTIAL SOURCE OF DAMAGE OF THE FILM FINDING THE FOLLOWING TO BE CONSIDERED: AFTER THE LASER MACHINE SEALS THE FILM TO THE CASSETTE MOLDED PART, A 100% LEAK TEST IS PERFORMED TO THE CASSETTE ASSEMBLIES. THERE IS A 100% LEAK TEST AFTER THIS SET IS COMPLETELY ASSEMBLED. NO SHARP OBJECTS ARE USED ON MANUFACTURING AREA. SAMPLE ANALYSIS: (B)(4) RECEIVED SAMPLE FROM CODE 050-87212,LOT# 10HR08089. A VISUAL ANALYSIS WAS PERFORMED TO THE ACTUAL SAMPLE AFTER LEAK TEST AND A HOLE WAS FOUND ON THE FILM OF THE CASSETTE. A LEAK TEST WAS PERFORMED BY INTRODUCING WATER INTO THE CASSETTE AND THE LEAK WAS CONFIRMED THE HOLE ON THE FILM CAUSING THE LEAK. VISUAL INSPECTION WITH THE MICROSCOPE WAS PERFORMED TO THE HARD PLASTIC OF THE CASSETTE AND DAMAGES FOUND ON THE HARD PLASTIC THAT MATCHES WITH THE HOLE ON THE FILM. THESE DAMAGES WERE POTENTIALLY CAUSED BY AN ACCIDENTAL HIT. ACCORDING TO THE MOLDED ON THE CASSETTE, IT WAS MOLDED IN 04/2010. THERE ARE NO NCR'S IN 2010 RELATED TO SHARPENED EDGES. PRODUCTION AND PROCESS LOGBOOKS WERE REVIEWED AND NO ISSUES WERE RECORDED RELATED TO SHARPNESS. THERE ARE NO PARTITION LINES IN THE DOME TO CAUSE A FLASH. MOLDING CORRECTIVE ACTION: NO SPECIFIC CORRECTIVE ACTION HAS BEEN IMPLEMENTED FOR SHARPNESS IN CASSETTE. SAMPLE ANALYSIS: THE REPORTED COMPLAINT IS CONFIRMED. THE POTENTIAL SOURCES OF DAMAGE ON THE CASSETTE FILM ARE: SHARP EDGES ON MUSHROOM HEADS, OR A BURR ON MUSHROOM HEADS. CONCLUSION: NO CAUSE IDENTIFIED DURING MANUFACTURING OF THIS PRODUCT. IT IS 100% INSPECTED FOR LEAKS. VISUAL ANALYSIS WAS PERFORMED WITH MICROSCOPE AND NO MALFORMATION WERE FOUND. FMC WILL MONITOR AND TREND PER PROCEDURE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REPORTED CASSETTE STARTED TO LEAK SOLUTION WHEN HE CONNECTED TO THE MACHINE. SAMPLE IS AVAILABLE. THERE IS NO INFORMATION OF ANY ILL EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PATIENT CONNECT PERITONEAL DIALYSIS TUBING SET FKX REYNOSA MANUFACTURING NA 10HR08089

    Patients

    Seq Age Sex Outcome Treatment
    1 NA LIBERTY DIALYSIS MACHINE: