BEUDAMED
    FDA Adverse Event Death Summary report: N

    ROTAFLOW

    MDR report key: 3946185 · Received June 16, 2014

    Report

    Report Number
    3946185
    Event Type
    Death
    Date Received
    June 16, 2014
    Date of Event
    May 30, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    KFM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN ICU, NOTED TO HAVE LOW BIS SCORE. NEURO EXAM REVEALED BLOWN PUPILS. APPROXIMATELY SAME TIME, ECMO CONSOLE NOTED TO BE DISPLAYING DASHES. GEL REAPPLIED TO FLOW PROBE BUT ISSUE NOT RESOLVED. PATIENT BECAME HEMODYNAMICALLY UNSTABLE, SBP 50-60, CODE MEDICATIONS ADMINISTERED. ECMO CIRCUIT NOTED TO HAVE EXTENSIVE AIR ON VENOUS LINES. CIRCUIT CLAMPED AND SWITCHED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351983 ROTAFLOW PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM MAQUET CARDIOVASCULAR LLC 701051712 *

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death