BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN EXT DL

    MDR report key: 4230800 · Received October 27, 2014

    Report

    Report Number
    8030665-2014-00836
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 2, 2014
    Manufacturer
    FRESENIUS MED CARE NORTH AMERICA 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 HAS NOT BEEN RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMITIES DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT REPORTED THAT DIALYSIS SOLUTION LEAKED OUT OF THE CASSETTE AND INTO THE CYCLER. PT STATED THAT THERE WAS FLUID LEAKING OUT OF THE DOOR. PT STATED THAT SHE COULD NOT DETERMINE IF THERE WAS A PUNCTURE ON THE TUBING SET. PT WAS ABLE TO COMPLETE TREATMENT AND HAD NO ADVERSE EFFECTS. SAMPLE HAS NOT BEEN RETURNED TO THE MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681062 LIBERTY CYCLER SET, SINGLE CONN EXT DL FKX FRESENIUS MED CARE NORTH AMERICA REYNOSA MFG 14AR08114

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER| PD SOLUTIONS