BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008K HEMODIALYSIS SYSTEM

    MDR report key: 3900205 · Received May 2, 2014

    Report

    Report Number
    2937457-2014-00742
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 4, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE PLANT'S INVESTIGATION. THERE HAVE BEEN NO ADVERSE EVENTS ASSOCIATED WITH THIS REPORTED ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A USER FACILITY THAT A UF CHECK VALVE ALARM OCCURRED BECAUSE THE VALVE HAD CRACKED AND FLUID BEGAN TO LEAK. THERE WAS PATIENT ON THE MACHINE AT THE TIME OF THE EVENT. THE PATIENT WAS TAKEN OFF THE MACHINE AND COMPLETED THERAPY ON OTHER MACHINE. THERE WAS NO MEDICAL INTERVENTION REQUIRED OR ADVERSE EVENT. THE MACHINE WAS PUT BACK INTO CIRCULATION AFTER THE CRACKED VALVE WAS REPLACED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266138 2008K HEMODIALYSIS SYSTEM KDI KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1