We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug & Device Products
    • FDAnews Books Library
    • Events
    • Form 483s Database
    • Publications
    • Webinar Training Pass
    • eCFR and Guidances
    • Books
  • Clinical Products
  • Advertising
  • White Papers
  • Contact Us
  • About Us
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » TGA Issues Update on Infections Linked to Heater-Cooler Devices

TGA Issues Update on Infections Linked to Heater-Cooler Devices

February 11, 2019

Australia’s Therapeutic Goods Administration issued an alert to say that nine Australians have been confirmed with Mycobacterium chimaera infections following heart surgery involving heater-cooler devices.

The confirmed cases of infection were associated with contaminated Stöckert Heater-Cooler 3T heater-cooler units that were manufactured before September 2014, the agency said.

The heater-cooler devices, used in operating theatres and intensive care units to control the temperature of blood, contain water tanks that provide temperature-controlled water. The TGA previously reported evidence to suggest that patients are infected when bacteria in the device's water tank becomes airborne in the operating room during surgery.

LivaNova, the sponsor of the Stöckert 3T devices in Australia, has taken steps to modify the 3T units to prevent aerosol dispersion.

View today's stories

Medical Devices Postmarket Safety

Upcoming Events

  • 08Feb

    Process and Design Validation for Devicemakers: A Deep Dive into Best Practices, Recent Trends and Regulatory Definitions

  • 09Feb

    The Inextricable Link Between Data Integrity and Quality Culture

  • 15Feb

    Advanced Compliance Writing CAPA: Mastering Failure Investigation and Root Cause Analysis

  • 16Feb

    Fundamentals of FDA Inspection Management: Reduce Anxiety, Increase Inspection Success

  • 22Feb

    Best Practices for Developing and Maintaining a GxP Training Matrix

  • 07Mar

    FDA’s Remote Assessments v. Remote Interactive Evaluations: Do You Really Know the Difference?

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Consortium Gets EU Funding to Develop Continuous Blood Pressure Monitoring Device

  • FDA Approves GSK’s Oral Drug for Chronic Kidney Disease-Related Anemia

  • Aspivix’s Carevix Cleared to Reduce Pain, Bleeding in Gynecological Procedures

  • FDA Warns That Energy Supplement Contains Active Cialis Ingredient

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing