BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 3833055 · Received March 25, 2014

    Report

    Report Number
    8030665-2014-00249
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    February 28, 2014
    Report Date
    March 1, 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. THIS REPORT IS ASSOCIATED WITH MDR # 8030665-2014-00248.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PT REPORTED THAT DURING TREATMENT, HIS CYCLER ALARMED WITH MULTIPLE MESSAGES. HE WAS NOT ABLE TO CLEAR THE ALARMS AND DISCONTINUED TREATMENT. WHEN DISASSEMBLING THE SET, HE FOUND FLUID INSIDE THE CASSETTE DOOR. HE COULD NOT FIND THE SOURCE OF THE LEAK. THE PT HAD BEEN ADVISED BY HIS PD NURSE TO SWITCH TO MANUAL TREATMENT IF HE COULD NOT COMPLETE HIS TREATMENT. THE PT WAS ADVISED TO DISCONTINUE USING THE CYCLER. THE SET WAS DISCARDED. DURING FOLLOW UP, THE PT'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
    173832 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL FKX REYNOSA MANUFACTURING 13JR08103

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR LIBERTY CYCLER