BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 4022980 · Received July 11, 2014

    Report

    Report Number
    8030665-2014-00546
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 15, 2014
    Report Date
    June 15, 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 EVALUATION 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) PATIENT REPORTED THAT HIS CYCLER ALARMED FOR AIR DETECTED IN THE CASSETTE DURING DRAIN 1. HE DISCONTINUED TREATMENT AND FOUND FLUID LEAKING FROM THE CASSETTE. HE FOUND A SMALL HOLE IN THE MEMBRANE OF THE CASSETTE. HE RETAINED THE SET AND IS MAKING IT AVAILABLE FOR EVALUATION. DURING FOLLOW UP, THE PATIENT REPORTED THAT HE HAS HAD CLEAR EFFLUENT. HE DID NOT HAVE ANY SIGNS OF INFECTION. HE HAD DISCUSSED THE INCIDENT WITH HIS PD NURSE AND WAS ADVISED TO TAKE PROPHYLACTIC ANTIBIOTIC VANCOMYCIN AND GENTAMICIN. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    407831 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX REYNOSA MANUFACTURING 14AR08025

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR LIBERTY CYCLER