BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2008K HEMODIALYSIS SYSTEM

    MDR report key: 3982869 · Received June 25, 2014

    Report

    Report Number
    2937457-2014-01583
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KDI
    PMA / PMN Number
    K994267
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS REPORTED ENTRAINMENT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A HEMODIALYSIS NURSE REPORTED THAT AIR ENTRAINMENT HAD OCCURRED DURING THE TREATMENT OF A PATIENT. THE NURSE WAS ABLE TO REMOVE THE AIR WITH NO EFFECT TO THE PATIENT. THE PATIENT WAS ABLE TO COMPLETE HEMODIALYSIS AND THERE WAS NO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370628 2008K HEMODIALYSIS SYSTEM KDI FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention BLOOD LINES| BICARBONATE| ACIDS| SALINE