BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./ EXT. DL

    MDR report key: 3193257 · Received June 25, 2013

    Report

    Report Number
    8030665-2013-00392
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Date of Event
    June 14, 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 MFR 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 NONCONFORMANCES DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE PATIENT CONNECTOR DURING TREATMENT. THE PATIENT WAS IN FILL ONE OF TREATMENT WHEN FLUID WAS NOTICED LEAKING FROM THE PATIENT CONNECTOR. THE CONNECTION WAS CHECKED AND THERE WAS NO INDICATION OF THE CONNECTION BEING LOOSE. PATIENT DID NOT HAVE ANY ADVERSE EFFECTS FROM THE EVENT. SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287335 LIBERTY CYCLER SET, SINGLE CONN./ EXT. DL FKX REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER