BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT.DL

    MDR report key: 2243582 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00079
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    April 24, 2011
    Report Date
    August 16, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE ANALYSIS: THE MANUFACTURING FACILITY RECEIVED THE ACTUAL SAMPLE AND PERFORMED A VISUAL INSPECTION AND SOME PINHOLES WERE FOUND CLOSE TO THE DOMES. A LEAK TEST WAS THEN PERFORMED TO THE CASSETTE BY INTRODUCING COLORANT SOLUTION AND THE CASSETTE LEAKED FROM THE PINHOLES ON THE CASSETTE DOMES. CONCLUSION: THE COMPLAINT IS DEEMED AS CONFIRMED; THE CASSETTE HAS PINHOLES THAT CAUSE THE LEAK. THE EVENT IS WITHIN THE SCOPE OF THE CURRENT CAPA, SO NEW CAPA IS NOT REQUIRED. (B)(4).

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT REPORTED THAT WHEN TAKING THE CASSETTE OUT OF THE MACHINE SHE SAW THAT THERE WAS FLUID COMING OUT OF THE DOOR. 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, SINGLE CONN./EXT.DL PERITONEAL DIALYSIS TUBING SET FKX REYNOSA MANUFACTURING NA 11BR08001

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LIBERTY DIALYSIS MACHINE