BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3132904 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13556
    Event Type
    Death
    Date Received
    May 29, 2013
    Date of Event
    May 3, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT THAT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTEDLY DUE TO A HEART ATTACK. THE PATIENT WAS HOSPITALIZED TWO DAYS PRIOR TO DEATH DUE TO AN INFECTION IN HIS TOE RELATED TO GOUT. THE REPORTER STATED THE PATIENT WAS ALSO FEELING WEAK. THE HOME PATIENT WAS REPORTED BEING TREATED WITH UNKNOWN ANTIBIOTICS FOR THE GOUT. PERITONEAL DIALYSIS THERAPY CONTINUED UP UNTIL THE TIME OF DEATH. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236980 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R EXTRANEAL| DIANEAL 2.5%