BEUDAMED
    FDA Adverse Event Summary report: N

    AVALON ELITE

    MDR report key: 1830060 · Received September 9, 2010

    Report

    Report Number
    1830060
    Date Received
    September 9, 2010
    Date of Event
    August 28, 2010
    Report Date
    September 8, 2010
    Manufacturer
    AVALON LABORATORIES, LLC
    Product Code
    DWF
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE PT WAS CANNULATED LAST WEEK AND PLACED ON VENOVENOUS ECMO. TWO DAYS LATER, THE PT SUFFERED A SUDDEN ONSET BRADYCARDIA, THEN RESUSCITATION STARTED. AN ECHOCARDIOGRAM WAS PERFORMED AND DEMONSTRATED A PERICARDIAL TAMPONADE, THE PT DID NOT SURVIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AVALON ELITE BI CAVAL LUMEN CATHETER DUAL LUMEN DWF AVALON LABORATORIES, LLC 10013 *

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA LONG-TERM ANTIBIOTICS| CARDIAC DRUGS