BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 4121194 · Received July 28, 2014

    Report

    Report Number
    8030665-2014-00578
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 26, 2014
    Manufacturer
    REYNOSA MFG
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, IT IS UNKNOWN HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE WAS NOT RETURNED TO THE MFR FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENT MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE PERITONEAL DIALYSIS (PD) PT REPORTED UPON COMPLETION OF THEIR TREATMENT ON (B)(6) 2014, THE CASSETTE LEAKED AND FLUID WAS FOUND AROUND THE CYCLER DOOR. A FOLLOW-UP CALL WITH THE PT'S PD NURSE REVEALED NO PERITONEAL DIALYSIS TREATMENTS WERE MISSED, NO SERIOUS INJURY OCCURRED. THE PT'S EFFLUENT EXPRESSED FROM THE PERITONEAL DIALYSIS CATHETER WAS CLEAR, AND THERE ARE NO SIGNS AND OR SYMPTOMS OF PERITONITIS. AS OF (B)(6) 2014, THE PT CONTINUES TO SUE CONTINUOUS CYCLER-ASSISTED PERITONEAL DIALYSIS (CCPD) THERAPY WITHOUT ANY FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439899 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX REYNOSA MFG

    Patients

    Seq Age Sex Outcome Treatment
    1 DELFLEX PD SOLUTION| LIBERTY CYCLER