BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3140052 · Received May 29, 2013

    Report

    Report Number
    8030665-2013-00337
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    April 30, 2013
    Report Date
    April 30, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION AND THE LOT NUMBER WAS NOT ABLE TO BE OBTAINED TO DATE. DISTRIBUTION RECORDS WERE REVIEWED TO IDENTIFY POTENTIAL LOTS OF THIS PRODUCT SHIPPED TO THE CUSTOMER WITHIN ONE MONTH PRIOR TO THE DATE OF EVENT. BATCH RECORDS FOR THE LOTS IDENTIFIED WERE REVIEWED AND CONFIRMED THERE WERE NO DEVIATIONS OR NONCONFORMANCE DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PATIENT WAS IN TREATMENT. UPON REMOVING THE TUBING SET, FLUID WAS FOUND IN THE CYCLER. THE ORIGIN OF THE LEAK COULD NOT BE IDENTIFIED. THE PATIENT DID NOT RECEIVE ANTIBIOTICS AND HAS HAD NO ADVERSE EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234446 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER