BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER CASSETTE

    MDR report key: 4230594 · Received October 22, 2014

    Report

    Report Number
    8030665-2014-00820
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 26, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE REYNOSA MFG.
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVAL AT THIS TIME AND WILL NOT BE AVAILABLE FOR EVAL. THE POST MARKET SURVEILLANCE DEPARTMENT HAS REQUESTED MEDICAL RECORDS AND INVESTIGATIONS ARE PENDING. A SUPPLEMENT MEDWATCH REPORT WILL BE SUBMITTED WHEN MEDICAL RECORDS ARE RECEIVED.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT A PT WAS ADMITTED DUE TO AN EPISODE OF PERITONITIS, WITHOUT ALLEGATION OF DEVICE MALFUNCTION. THE NURSE STATED THE SOURCE PERITONITIS WAS UNK. THE PT WAS ASSISTED BY A CAREGIVER TO COMPLETE PERITONEAL DIALYSIS TREATMENTS. THE PT WAS IN THE PROCESS OF SWITCHING TO HEMODIALYSIS THERAPY AND WAS BEING PLACED IN A LONG-TERM CARE FACILITY UPON HOSPITAL DISCHARGE. THE PT'S MEDICAL RECORDS WERE REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670992 LIBERTY CYCLER CASSETTE FKX FRESENIUS MEDICAL CARE REYNOSA MFG. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R DELFLEX-PD SOLUTION| LIBERTY CYCLER