BEUDAMED
    FDA Adverse Event Death Summary report: N

    DUMVETINVIAFLEX

    MDR report key: 2089030 · Received May 13, 2011

    Report

    Report Number
    6000001-2011-04049
    Event Type
    Death
    Date Received
    May 13, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BAXTER HEALTHCARE - JAYUYA
    Product Code
    KPE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL MEDWATCH REPORT (6000001-2011-04049) WAS PREVIOUSLY SUBMITTED IN ERROR REGARDING THIS COMPLAINT. THE PRODUCT INVOLVED IN THE ADVERSE EVENT IS A DRUG (B)(4) MANUFACTURED BY BAXTER; THEREFORE, THIS EVENT IS NOT REPORTABLE. BAXTER'S REGULATORY AFFAIRS DEPARTMENT WILL BE REPORTING THIS DRUG ADVERSE EVENT (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE REPORTED HAS BEEN REQUESTED FROM THE CUSTOMER BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, AND/OR UPON CONCLUSION OF BAXTER'S INVESTIGATION A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A CUSTOMER REPORTED THE DEATH OF A (B)(6). ON (B)(6) 2011, BAXTER CONTACTED THE VETERINARIAN ((B)(6)) AT THE (B)(6) HOSPITAL REGARDING THE REPORT OF ANIMAL DEATH. THE (B)(6)STATED THAT A POST MORTEM NECROPSY WAS PERFORMED. THE DRUG ADMINISTERED PRIOR TO THE INCIDENT WAS MANUFACTURED BY (B)(4), HAD BEEN DRAWN INTO A 60ML SYRINGE FROM ITS BAXTER VIAFLEX SOLUTION BAG AND ADMINISTERED TO THE ANIMAL INTRAVENOUS PUSH (IVP) THROUGH AN INTRAVENOUS (IV) LINE. SUBSEQUENTLY, THE ANIMAL SUFFERED AN EPISODE OF ANAPHYLACTIC SHOCK POST INJECTION (PERIOD OF TIME UNREPORTED) RESULTING IN DEATH TO THE ANIMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUMVETINVIAFLEX CONTAINER, I.V. KPE BAXTER HEALTHCARE - JAYUYA P261735

    Patients

    Seq Age Sex Outcome Treatment
    1 20 MO Death| O