BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3964344 · Received June 19, 2014

    Report

    Report Number
    8030665-2014-00492
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 19, 2014
    Report Date
    May 20, 2014
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    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 HOSPITAL NURSE REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT WAS IN A FILL CYCLE WHEN THE CYCLER ALARMED FOR AIR DETECTED IN THE CASSETTE. THERE WAS FLUID LEAKING FROM THE CYCLER DOOR. TREATMENT WAS CANCELED AND WHEN THE CASSETTE WAS REMOVED SHE FOUND A HOLE IN THE CASSETTE. THE PATIENT COMPLETED TREATMENT ON ANOTHER CYCLER. THE SET WAS DISCARDED. DURING FOLLOW UP THE NURSE REPORTED THAT THE PATIENT DID NOT DEVELOP AN INFECTION AND WAS NOT TREATED WITH ANTIBIOTIC. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359621 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR LIBERTY CYCLER