BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 4063373 · Received August 14, 2014

    Report

    Report Number
    8030665-2014-00622
    Event Type
    Malfunction
    Date Received
    August 14, 2014
    Date of Event
    July 12, 2014
    Report Date
    July 12, 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 FINDING A FLUID LEAK FOLLOWING HIS TREATMENT. WHEN HE OPENED THE CASSETTE DOOR THERE WAS FLUID ON THE TUBING SET. THE SET WAS RETAINED ND IS AVAILABLE FOR EVAL. DURING FOLLOW UP, HIS PD NURSE REPORTED THAT HIS EFFLUENT WAS CLEAR. HE DID NOT HAVE SIGNS OF INFECTION. HE WAS TREATED WITH PROPHYLACTIC ANTIBIOTIC 500 MG CYPRO. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488103 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX REYNOSA MANUFACTURING 14BR08029

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR LIBERTY CYCLER