BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUEL PATIENT CONNECT

    MDR report key: 2241665 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00052
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    December 23, 2010
    Report Date
    August 4, 2011
    Manufacturer
    REYNOSA MFG.
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW: THE DHR FOR THIS PRODUCT WAS REVIEWED AND THE FOLLOWING WAS FOUND: THE ASSEMBLY OF THE PRODUCT DID NOT HAVE ANY NCR OR DEVIATIONS DOCUMENTED DURING THE MFG PROCESS RELATED TO THE 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. SAMPLE ANALYSIS: THE MFG FACILITY PERFORMED A VISUAL ANALYSIS TO THE ACTUAL SAMPLE RECEIVED AND A HOLE WAS FOUND ON THE FILM OF THE CASSETTE. A LEAK TEST WAS THEN PERFORMED BY INTRODUCING COLORED LIQUID INTO THE CASSETTE AND THE LEAK WAS CONFIRMED, THE HOLE ON THE FILM CAUSES THE LEAK. CONCLUSION: THERE IS NO CAUSE IDENTIFIED DURING MFG 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 MALFORMATIONS 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 AS A CONTINUOUS IMPROVEMENT INITIATIVE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT REPORTED THAT SHE RECEIVED AN M31 MESSAGE ON THE CYCLER MACHINE AND WHEN SHE OPENED THE CASSETTE DOOR IN THE MORNING SHE NOTICED SOLUTION LEAKING OUT FROM CYCLER. THERE IS NO REPORTED ILL EFFECT TO THE PT AND THE SAMPLE IS AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUEL PATIENT CONNECT PERITONEAL DIALYSIS TUBING SET FKX REYNOSA MFG. NA 10KR08102

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LIBERTY DIALYSIS MACHINE