BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN/EXT DL

    MDR report key: 2243496 · Received August 19, 2011

    Report

    Report Number
    8030665-2011-00073
    Event Type
    Malfunction
    Date Received
    August 19, 2011
    Date of Event
    April 5, 2011
    Report Date
    August 15, 2011
    Manufacturer
    REYNOSA MFG
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO SAMPLE RETURNED FOR EVAL, THEREFORE THE COMPLAINT IS DEEMED AS UNCONFIRMED. 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 DURING TREATMENT THERE WERE ALARMS, THE CASSETTE COMPARTMENT WAS WET AND IT WAS OBSERVED THAT THE FLUID WAS COMING FROM THE CASSETTE. THERE IS NO REPORT OF PT ILL EFFECT. THERE IS NO SAMPLE AVAILABLE FOR ANALYSIS.

    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 MFG NA 10SR08003

    Patients

    Seq Age Sex Outcome Treatment
    1 NI LIBERTY DIALYSIS MACHINE