BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PT CONNECT

    MDR report key: 3964330 · Received June 19, 2014

    Report

    Report Number
    8030665-2014-00489
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 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 EVAL 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) PT REPORTED HER CYCLER HAD AN "SIR DETECTED IN CASSETTE" ALARM DURING FILL 1 AND SHE COULD NOT CLEAR IT. SHE DISCONTINUED TREATMENT. WHEN REMOVING THE CASSETTE THERE WAS FLUID IN THE CASSETTE DOOR. SHE FINISHED TREATMENT MANUALLY. SHE WAS ADVISED TO CONTACT HER PD NURSE. THE SET HAS BEEN MADE AVAILABLE FOR EVAL. DURING FOLLOW UP THE PT REPORTED THAT HER EFFLUENT HAS REMAINED CLEAR. SHE INFORMED HER NURSE OF THE LEAK. SHE HAS NOT HAD ANY SIGNS OF INFECTION. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359363 LIBERTY CYCLER SET, DUAL PT CONNECT FKX REYNOSA MANUFACTURING

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY CYCLER