BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 3802214 · Received March 24, 2014

    Report

    Report Number
    8030665-2014-00241
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 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 DURING TREATMENT THAT THE CYCLER WAS NOT DRAINING HIM AS EXPECTED. HE NOTICED FLUID LEAKING FROM THE CASSETTE AREA AND STOPPED TREATMENT. THE PATIENT COMPLETED HIS TREATMENT MANUALLY. HE DISCARDED THE SET. DURING FOLLOW UP, THE PATIENT'S PD NURSE STATED HIS EFFLUENT HAS REMAINED CLEAR. THERE WERE NO SIGNS OF INFECTION AND NO PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171327 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX REYNOSA MANUFACTURING 13NR08820

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR LIBERTY CYCLER