BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE PATIENT CONN

    MDR report key: 3802233 · Received March 24, 2014

    Report

    Report Number
    8030665-2014-00238
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 20, 2014
    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 HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT REPORTED WHILE REMOVING THE TUBING SET FROM THE CYCLER FLUID BEGAN TO LEAK. THE PATIENTS PD NURSE WAS CONTACTED ON (B)(6) 2014. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. NO ADVERSE EVENTS REPORTED AT THIS TIME. SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171343 LIBERTY CYCLER SET, SINGLE PATIENT CONN FKX REYNOSA MANUFACTURING 13PR08039

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER