BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN/EXT. DL

    MDR report key: 3963973 · Received May 8, 2014

    Report

    Report Number
    8030665-2014-00354
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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'S WIFE REPORTED THAT DURING DRAIN 0, THE CYCLER WAS NOT DRAINING. WHILE TROUBLESHOOTING, SHE ADVANCED TO FILL 1 AND THE PATIENT BEGAN TO FILL A SMALL AMOUNT AND THE CYCLER ALARMED FOR A HEATER BAG ISSUE. THE TREATMENT WAS CANCELLED. WHEN SHE OPENED THE CASSETTE DOOR, SHE FOUND FLUID HAD LEAKED. SHE WAS ADVISED TO DISCONTINUE TREATMENT AND CONTACT THE PD NURSE. SHE RETAINED THE SET AND WAS INSTRUCTED ON HOW TO RETURN IT. DURING FOLLOW UP, THE PATIENT'S PD NURSE REPORTED THAT THE PATIENT WAS VISITED ON (B)(6) 2014. HIS EFFLUENT WAS CLEAR AND HE DID NOT HAVE ANY SIGNS OF PERITONITIS. HE WAS NOT TREATED WITH ANTIBIOTICS. ON (B)(6) 2014, DUE TO PREEXISTING MEDICAL CONDITIONS NOT RELATED TO HIS KIDNEY FUNCTION THE PATIENT CHOSE TO VOLUNTARILY DISCONTINUE TREATMENT WITH ALL FRESENIUS MEDICAL PRODUCTS. HE EXPIRED (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277929 LIBERTY CYCLER SET, SINGLE CONN/EXT. DL FKX REYNOSA MANUFACTURING 13NR08148

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR LIBERTY CYCLER