BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3904931 · Received May 28, 2014

    Report

    Report Number
    8030665-2014-00449
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 30, 2014
    Report Date
    May 1, 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

    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 FINDING A FLUID LEAK FOLLOWING HIS TREATMENT. WHEN HE OPENED THE CASSETTE DOOR, THERE WAS FLUID LEAKING. THE SET WAS DISCARDED. DURING FOLLOW UP, HIS PD NURSE REPORTED THAT HIS EFFLUENT WAS CLEAR. HE DID NOT HAVE SIGNS OF INFECTION. HE WAS NOT PRESCRIBED ANY ANTIBIOTICS. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    315016 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX REYNOSA MANUFACTURING 13SR08016

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR LIBERTY CYCLER