BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2243577 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00086
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    May 7, 2011
    Report Date
    August 17, 2011
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE MANUFACTURING FACILITY RECEIVED THE ACTUAL SAMPLE FOR EVALUATION. SAMPLE ANALYSIS: A VISUAL INSPECTION OF THE SAMPLE WAS PERFORMED AND NO DAMAGES OR PINHOLES ON THE CASSETTE FILM WERE FOUND. A LEAK TEST WAS THEN PERFORMED BY INTRODUCING COLORANT SOLUTION AND NO LEAKS WERE FOUND. CONCLUSION: THE COMPLAINT IS DEEMED AS UNCONFIRMED; THE CASSETTE DID NOT LEAK. NO FURTHER INVESTIGATION REQUIRED. EVENT DATA WILL BE TRENDED PER QUALITY DATA ANALYSIS PROCEDURE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT, REPORTED THAT HE HAD A LEAKING CASSETTE. HE HAD JUST COMPLETED HIS TREATMENT AND REMOVED THE CASSETTE WHEN HE NOTICED IT WAS LEAKING. THERE IS NOT REPORT OF PT ILL EFFECT. THE SAMPLE IS AVAILABLE FOR EVALUATION.

    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 11BR08010

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LIBERTY DIALYSIS MACHINE