BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERITONEAL DIALYSIS CYCLER

    MDR report key: 2536566 · Received April 13, 2012

    Report

    Report Number
    MW5025013
    Event Type
    Other
    Date Received
    April 13, 2012
    Date of Event
    October 28, 2011
    Report Date
    April 13, 2012
    Manufacturer
    LIBERTY
    Product Code
    FKX
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DIALYSIS PT RECEIVED A RECALL LETTER FOR LIBERTY CYCLER BECAUSE OF OVERFILLING. HAD OVERFILLING ONE TIME WITH THE NURSE AND 5 TIMES WITHOUT THE NURSE. FELT FULL BUT DENIED OTHER SYMPTOMS. RECEIVED THE CYCLER IN (B)(6) 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERITONEAL DIALYSIS CYCLER SW VERSION 2.8.2 027 FKX LIBERTY

    Patients

    Seq Age Sex Outcome Treatment
    1