BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3964326 · Received June 19, 2014

    Report

    Report Number
    8030665-2014-00490
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Report Date
    May 20, 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 FINDING A LEAK OF FLUID IN HIS BED. THE LEAK WAS COMING FROM THE CONNECTOR BETWEEN THE PATIENT LINE FROM THE CYCLER AND THE PATIENT'S CATHETER. HE REPORTED THAT HE DID NOT TIGHTEN THE CONNECTION ENOUGH. HE FINISHED TREATMENT MANUALLY THAT NIGHT. HE IS MAKING THE SET AVAILABLE FOR EVALUATION. DURING FOLLOW UP THE PATIENT'S PD NURSE REPORTED THAT HE WAS ALREADY BEING TREATED FOR A PRE-EXISTING INFECTION WITH ANTIBIOTICS VANCOMYCIN AND FORTAZ. THE INFECTION WAS DIAGNOSED PRIOR TO THIS EVENT. HE WAS NOT PRESCRIBED ANY ADDITIONAL TREATMENT. HIS MOST RECENT PF EFFLUENT CULTURE WAS NEGATIVE FOR GROWTH AND THE PRE-EXISTING INFECTION WAS CONSIDERED FULLY TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    359645 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX REYNOSA MANUFACTURING 14AR08023

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR LIBERTY CYCLER