BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBERTY CYCLER SET, DUAL PATIENT CONNECT

    MDR report key: 2781816 · Received October 5, 2012

    Report

    Report Number
    8030665-2012-00290
    Event Type
    Malfunction
    Date Received
    October 5, 2012
    Date of Event
    September 8, 2012
    Report Date
    September 8, 2012
    Manufacturer
    REYNOSA MFG
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PT HAS REPORTED THAT THE DIALYSIS SOLUTION IS LEAKING OUT OF THE CASSETTE AND INTO THE CYCLER. PT STATED THAT SHE WAS IN TREATMENT AND NOTICED THERE WAS SOLUTION LEAKING FROM THE CYCLER. PD NURSE REPORTS THAT PT HAS NOT EXPRESSED OR DEMONSTRATED ANY ILL EFFECTS OR HAD ANY ANTIBIOTICS ADMINISTERED. THERE IS NO SAMPLE AVAILABLE FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 LIBERTY DIALYSIS CYCLER