BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3853027 · Received May 23, 2014

    Report

    Report Number
    2937457-2014-00881
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 26, 2014
    Report Date
    April 26, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW; WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCT BEING USED AT THE TIME OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PHYSICIAN'S ASSESSMENT OF THE REPORTED INFORMATION AND THE PLANT'S INVESTIGATION. THE CYCLER WAS MOVED TO THE CLINIC FROM THE NURSING HOME WHERE THE EVENT OCCURRED, AND WILL BE RETURNING TO THE FRESENIUS PLANT FOR AN EVALUATION. THE RELATED MDRS #293457-2014-00881 AND 8030665-2014-00445.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DIALYSIS CLINIC THAT THE PATIENT WAS TAKEN TO THE HOSPITAL AFTER BEING FOUND UNRESPONSIVE DURING HER PERITONEAL DIALYSIS TREATMENT. THE PATIENT REQUIRED INTUBATION DUE TO RESPIRATORY ARREST. SHE REMAINED ON THE VENTILATOR FOR A DAY OR TWO AND IS NOW BREATHING ON HER OWN. THE PATIENT IS CURRENTLY IN THE HOSPITAL. IT IS NOT KNOWN HOW LONG THE PATIENT WAS UNRESPONSIVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309127 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R DELFLEX| DEXTROSE SOLUTION| LIBERTY CYCLER SET