BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN/EXT DL

    MDR report key: 3063312 · Received March 1, 2013

    Report

    Report Number
    8030665-2013-00128
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 5, 2013
    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 FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MFG RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECS.

    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 STATED THAT WHILE REMOVING THE CASSETTE, PATIENT NOTICED FLUID INSIDE THE CYCLER DOOR. PATIENT ALSO STATED THAT A PINHOLE LOCATED IN THE MIDDLE OF THE LEFT DOME ON THE SOFT SIDE OF THE CASSETTE WAS THE SOURCE OF THE LEAK. THE SAMPLE WAS DISCARDED. PATIENT HAD NO ILL EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90221 LIBERTY CYCLER SET, SINGLE CONN/EXT DL LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MFG 12LR08035

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER