BEUDAMED
    FDA Adverse Event Death Summary report: N

    AVANTA FLUID MANAGEMENT INJECTION SYSTEM

    MDR report key: 2023878 · Received March 14, 2011

    Report

    Report Number
    2520313-2011-00004
    Event Type
    Death
    Date Received
    March 14, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 14, 2011
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSTEM SERVICE CHECK OF THE INJECTOR WAS OFFERED TO THE CUSTOMER, BUT WAS REFUSED. THE SITE HAS REFUSED MEDRAD ACCESS TO THE EQUIPMENT. THE BATCH NUMBERS OF THE DISPOSABLES THAT WERE IN USE DURING THE REPORTED EVENT WERE NOT PROVIDED.

    Description of Event or Problem · 1

    WE RECEIVED THE FOLLOWING INFO: DURING A DIAGNOSTIC CORONARY ANGIOGRAM OF THE LEFT CORONARY ARTERY, THE PT EXPERIENCED VENTRICULAR FIBRILLATION REQUIRING CARDIOPULMONARY RESUSCITATION. RESUSCITATION EFFORTS WERE UNSUCCESSFUL AND THE PT EXPIRED. THE CUSTOMER REPORTED THAT FLUOROSCOPIC IMAGES REVEALED LARGE QUANTITIES OF AIR IN THE CORONARY ARTERIES AND AORTA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVANTA FLUID MANAGEMENT INJECTION SYSTEM ANGIOGRAPHIC INJECTOR DXT MEDRAD AVA 500 PEDL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death AVANTA SINGLE-PATIENT DISPOSABLE SET| AVANTA MULTI-PATIENT DISPOSABLE SET