BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 4230655 · Received October 27, 2014

    Report

    Report Number
    2937457-2014-03046
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    September 28, 2014
    Report Date
    September 28, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 PRODUCTS BEING USED AT THE TIME OF THE EVENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON FINAL REVIEW OF MEDICAL RECORDS BY POST MARKET CLINICAL AND COMPLETION OF THE PLANT'S INVESTIGATION. THIS PRODUCT REPORT IS RELATED TO ONE OTHER PRODUCT REPORT FOR THE SAME EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE NURSE THAT THE PATIENT HAD A CARDIAC ARREST; SHE WAS RESUSCITATED AND TRANSFERRED TO ICU. ON (B)(6) 2014, THE PATIENT WAS MOVED TO A STEP-DOWN UNIT AND IS RECOVERING FROM A MYOCARDIAL INFARCTION, SHE CONTINUES WITH PD TREATMENTS. THE LIBERTY CYCLER WAS "SENT DOWNSTAIRS AFTER THE EVENT". REPORTEDLY THE CYCLER WAS OK TO USE AND HAS BEEN RETURNED TO SERVICE AT THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681229 LIBERTY CYCLER FKX FRESENIUS MEDICAL CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R LIBERTY CYCLER TUBING