BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2243555 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00093
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    May 18, 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
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURING FACILITY RECEIVED COMPANION SAMPLES FOR EVALUATION AND THE FOLLOWING ARE THE RESULTS OF THE ANALYSIS: SAMPLE ANALYSIS: A VISUAL INSPECTION OF THE SAMPLE WAS PERFORMED AND NO DEFECTS WERE FOUND. A FUNCTIONAL TEST WAS THEN PERFORMED IN ORDER TO FIND ANY LEAKS. NO LEAKS OR ALARMS WERE FOUND DURING THE SIMULATED TREATMENT. THE COMPLAINT IS DEEMED AS UNCONFIRMED. NO FURTHER INVESTIGATION IS REQUIRED. EVENT DATA WILL BE TRENDED PER QUALITY DATA ANALYSIS PROCEDURE.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT REPORTED HE WAS GETTING AN ALARM. WHEN HE TOOK CASSETTE OUT OF THE MACHINE HE NOTICED IT WAS WET INSIDE THE CASSETTE DOOR HOUSING. THERE IS NO 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