BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XENIUM+

    MDR report key: 3063674 · Received April 17, 2013

    Report

    Report Number
    1416980-2013-09540
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 26, 2013
    Manufacturer
    NIPRO CORPORATION
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED NAUSEA, VOMITING, HYPOTENSION, HEADACHE AND PASSED OUT DURING HEMODIALYSIS. THE TREATING PHYSICIAN COULD NOT CONFIRM THE SYMPTOMS WERE RELATED TO THE DIALYZER. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165171 XENIUM+ DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI NIPRO CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1