BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROTAFLOW 2-PUMPS CONSOLE

    MDR report key: 4805171 · Received May 28, 2015

    Report

    Report Number
    3008355164-2015-00107
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    May 5, 2015
    Report Date
    May 5, 2015
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING PT ECLS SUPPORT, A SPARK WAS NOTED AT THE WALL SOCKET ELECTRICAL CONNECTION FOR THE DEVICE. THE DEVICE SWITCHED TO BATTERY SUPPORT. THE CLINICAL DECISION WAS MADE TO CHANGE THE ENTIRE SYSTEM TO THE BACK-UP SYSTEM. SUPPORT WAS TEMPORARILY CREASED AND THE ECLS CIRCUIT WAS SWITCHED TO THE BACK-UP SYSTEM. ECLS- EXTRA CORPOREAL LUNG SUPPORT. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346082 ROTAFLOW 2-PUMPS CONSOLE DTQ MAQUET CARDIOPULMONARY AG MCP00703695

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention