BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN. EXT. DL

    MDR report key: 2864507 · Received December 6, 2012

    Report

    Report Number
    8030665-2012-00376
    Event Type
    Malfunction
    Date Received
    December 6, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    REYNOSA MFG
    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 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 OCCURRENCE. 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 IS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PATIENT RECEIVED AN ALARM IN FILL ONE AND HAD TO RESET UP. WHEN PATIENT REMOVED THE CASSETTE, SHE NOTICED FLUID LEAKING INTO THE CYCLER. PATIENT STATES SHE HAS HAD NO ILL EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, SINGLE CONN. EXT. DL LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MFG

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER