BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECTOR

    MDR report key: 2921961 · Received January 15, 2013

    Report

    Report Number
    8030665-2013-00038
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 19, 2012
    Manufacturer
    REYNOSA MFG
    Product Code
    FKX
    PMA / PMN Number
    043363
    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 EVAL, 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 THE EVENT. BATCH RECORDS FOR THE LOTS IDENTIFIED WERE REVIEWED AND CONFIRMED THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG 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 WHEN FLUID WAS NOTICED DRIPPING FROM THE CYCLER. UPON OPENING THE CASSETTE DOOR, MOISTURE WAS NOTICED INSIDE THE CYCLER. PATIENT HAD NO ILL EFFECTS. SAMPLE WAS DISCARDED BY THE PATIENT; SAMPLE IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22237 LIBERTY CYCLER SET, DUAL PATIENT CONNECTOR LIBERY DIALYSIS CYCLER TUBING FKX REYNOSA MFG

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERY DIALYSIS CYCLER