BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT DL

    MDR report key: 3063316 · Received March 1, 2013

    Report

    Report Number
    8030665-2013-00123
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 3, 2013
    Report Date
    February 3, 2013
    Manufacturer
    ERIKA DE REYNOSA, S.A. DE C.V.
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED AS A PRECAUTION AND PATIENT HAD NO ILL EFFECTS. PATIENT NOTICED FLUID ON THE FLOOR AND ON THE SOLUTION BAG LINE AFTER TREATMENT. PATIENT STATED THAT THE AREA AROUND THE PUMP MODULE WAS COMPLETELY DRY. SAMPLE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90526 LIBERTY CYCLER SET, SINGLE CONN./EXT DL LIBERTY DIALYSIS CYCLER TUBING FKX ERIKA DE REYNOSA, S.A. DE C.V. 12LR08073

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER