BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 3020544 · Received March 21, 2013

    Report

    Report Number
    2937457-2013-00037
    Event Type
    Injury
    Date Received
    March 21, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 21, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT CONTACTED TECH SUPPORT AND REPORTED SHE THOUGHT SHE WAS HAVING A HEART ATTACK, SO THE TREATMENT WAS DISCONTINUED AND SHE WAS TAKEN TO THE HOSPITAL. UPON FURTHER FOLLOW-UP, THE PT'S DAUGHTER REPORTED THE PT WAS EVALUATED FOR 6 HOURS AND DISCHARGED HOME WITH A DIAGNOSIS OF CONGESTIVE HEART FAILURE. THE PT'S DAUGHTER ALSO EXPLAINED THE PT WAS GETTING USED TO DOING MORE DIALYSIS. THE PT WAS USING TWO 5 LITER BAGS FOR TREATMENT AND WAS CHANGED TO THREE 5 LITER BAGS FOR TREATMENT. THE PT'S DAUGHTER DENIED ISSUES WITH THE CYCLER AND DENIED LARGE DRAINS AND STATED THE PT CONTINUED TO USE THE SAME CYCLER WITHOUT FURTHER ISSUE. THE IQ DATA AND MEDICAL RECORDS HAVE NOT BEEN RECEIVED AT THE TIME OF THIS WRITING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118138 LIBERTY CYCLER PERITONEAL DIALYSIS CYCLER FKX FRESENIUS MEDICAL CARE NORTH AMERICA LIB

    Patients

    Seq Age Sex Outcome Treatment
    1 Other LIBERTY CYCLER SET