BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2894677 · Received December 27, 2012

    Report

    Report Number
    8030665-2012-00417
    Event Type
    Malfunction
    Date Received
    December 27, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 5, 2012
    Manufacturer
    REYNOSA MFG
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT HAS REPORTED THAT DIALYSIS SOLUTION WAS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. WHEN THE TUBING SET WAS REMOVED IN THE MORNING FOLLOWING TREATMENT, IT HAD LEAKED INTO THE CYCLER. PT STATED THAT THE TUBING DISCONNECTED IN THE AREA WHERE THE TUBING MEETS THE CASSETTE. PT HAD NO ILL EFFECTS. A SAMPLE OF THE SAME LOT NUMBER IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, DUAL PATIENT CONNECT LIBERTY DIALYSIS CYCLER TUBING FKX REYNOSA MFG 12ER08037

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER