BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT.DL

    MDR report key: 2243580 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00088
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    February 6, 2011
    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
    AZ, 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 MANUFACTURING PROCESS RELATED TO THIS FAILURE MODE. 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. THERE WERE NO ISSUES REPORTED DURING PROCESSES FOR LOT 10NR08021. SAMPLE ANALYSIS: THE MANUFACTURING FACILITY RECEIVED THE ACTUAL SAMPLE AND PERFORMED A VISUAL ANALYSIS AND A PINHOLE WAS FOUND ON THE FILM OF THE CASSETTE. A FUNCTIONAL TEST WAS THEN PERFORMED BY INTRODUCING COLOR LIQUID INTO THE CASSETTE AND THE LEAK WAS CONFIRMED, THE PINHOLE ON THE FILM CAUSES THE LEAK. CONCLUSION: THE COMPLAINT IS CONFIRMED, HOWEVER, THERE IS NO CAUSE IDENTIFIED DURING MANUFACTURING OF THIS PRODUCT SINCE THE PRODUCT IS 100% INSPECTED FOR LEAKS PRIOR TO PACKAGING. A VISUAL ANALYSIS OF THE CASSETTE WITH THE MICROSCOPE AND NO MALFUNCTIONS SUCH AS FLASHES THAT COULD CAUSE FILM DAMAGE WERE FOUND. CAPA (B)(4) WAS OPENED TO ADDRESS CORRECTIVE ACTIONS FOR CASSETTE LEAKS. (B)(4) HAS BEEN OPENED TO REDUCE THE COMPLAINT RATE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REPORTED THAT THE CASSETTE WAS LEAKING WHILE PRIMING. THE ALARM ON THE CYCLER STATED BALLOON PUNCTURE. THERE IS NO REPORT OF PATIENT ILL EFFECT. SAMPLE IS AVAILABLE FOR EVALUATION.

    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 10NR08021

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LIBERTY DIALYSIS MACHINE