BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 3303456 · Received August 14, 2013

    Report

    Report Number
    8030665-2013-00534
    Event Type
    Malfunction
    Date Received
    August 14, 2013
    Date of Event
    July 17, 2013
    Report Date
    July 18, 2013
    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 ACTUAL DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, HOWEVER, A COMPANION SAMPLE FROM THE SAME LOT WSA RETURNED FOR INVESTIGATION AND NO DEFECTS WERE NOTED. IN ADDITION, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MFR. THERE WERE NO DEVIATIONS OR NONCONFORMANCES DURING THE MFG PROCESS. IN ADDITION, THE BATCH RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION. THIS REPORT IS RELATED TO MDRS: 8030665-2013-00526, 8030665-2013-00527, 8030665-2013-00528, 8030665-2013-00529, 8030665-2013-00530, 8030665-2013-00531.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER EVERY NIGHT FOR THE PAST WEEK. PT WAS IN TREATMENT. UPON REMOVING THE TUBING SET, SOLUTION WS FOUND INSIDE THE CYCLER. THER ORIGIN OF THE LEAK COULD NOT BE IDENTIFIED. PT DID NOT RECEIVE ANY PROPHYLACTIC ANTIBIOTICS AND HAS HAD NO ADVERSE EFFECTS. A COMPANION SAMPLE OF THE SAME LOT NUMBER IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391710 LIBERTY CYCLER SET, DUAL PATIENT CONNECT FKX REYNOSA MANUFACTURING 13DR08978

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER