BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3911955 · Received May 13, 2014

    Report

    Report Number
    8030665-2014-00370
    Event Type
    Malfunction
    Date Received
    May 13, 2014
    Date of Event
    April 14, 2014
    Report Date
    April 14, 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

    THE DEVICE HAS NOT BEEN RETURNED FOR EVAL 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) PT'S CAREGIVER REPORTED THAT THE CYCLER ALARMED WITH SEVERAL ALARMS DURING TREATMENT AND WAS MAKING AN UNUSUAL NOISE. WHILE TROUBLESHOOTING THE ALARMS THE PT WAS DISCONNECTED AND DISCONTINUED TREATMENT. WHEN THE CASSETTE DOOR WAS OPENED THERE WAS FLUID LEAKING. THE PT WAS ADVISED TO RETAIN THE SET AND RETURN IT FOR EVAL, HOWEVER THERE HAS BEEN NO FOLLOW UP RESPONSE. DURING FOLLOW UP THE PT'S PD NURSE REPORTED THE PT'S EFFLUENT HAS REMAINED CLEAR. SHE DID NOT HAVE ANY SIGNS OF INFECTION AND NO ANTIBIOTICS WERE PRESCRIBED. THE NURSE REPORTED THAT SHE BELIEVES THE SET WAS BEING RETURNED FOR EVAL. NO ADVERSE EVENT REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285314 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX REYNOSA MANUFACTURING 13PR08055

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR LIBERTY CYCLER