BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3791907 · Received January 22, 2014

    Report

    Report Number
    8030665-2014-00088
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    November 27, 2013
    Report Date
    December 27, 2013
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS NURSE REPORTED A LEAK OCCURRED DURING PATIENT'S TREATMENT APPROXIMATLEY A MONTH AGO. THE LEAK WAS COMING FROM THE CASSETTE. PATIENT WAS GIVEN AN UNKNOWN ANTIBIOTIC PROPHYLACTICALLY. PATIENT DID NOT HAVE ANY SIGNS OR SYMPTOMS OF INFECTION AND HIS FLUID HAS REMAINED CLEAR. PATIENT HAS SWITCHED TO MANUALS SINCE THE LEAK AND HAS BEEN FEELING WELL. SAMPLES WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    53255 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR LIBERTY CYCLER