Terumo HX2 Heater-Cooler System: Bacteria Infection Lawsuits
Terumo HX2 Temperature Management System, a heater-cooler device manufactured by Michigan-based Terumo Cardiovascular Systems Corp., provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.
The heater-cooler device controls the patient’s temperature by circulating heated and cooled water within a closed loop of tubes. However, the controversial device has recently been linked to mycobacteria, a harmful bacteria.
Devices contaminated with mycobacteria and other types of bacteria can pose a risk of infecting patients, through indirect contact.
According to the FDA, contaminated water could potentially enter other parts of the device and aerosolize, transmitting bacteria through the air and through the device’s exhaust vent into the environment and to the patient. Contaminated devices can emit aerosols of M. chimaera into the operating room’s air, which could then enter a patient’s open chest, causing serious infections.
Terumo HX2 Heater-Cooler Device Linked To Bacterial Infection
The U.S. Centers for Disease Control & Prevention and the U.S. Food and Drug Administration (FDA) are currently investigating reports that heater-cooler systems, such as the Terumo HX2 Temperature Management System, has been linked to a rare bacterial infection caused by Mycobacterium chimaera, a type of bacteria known as nontuberculous mycobacterium (NTM).
The CDC issued a release October 2016 warning healthcare providers and patients about the potential risk of infection from similar devices used during open heart (open-chest) surgery.
The CDC estimates that in hospitals where at least one infection has been identified, the risk of a patient getting an infection from the bacteria was between about 1 in 100 and 1 in 1,000.
Common Symptoms of Nontuberculous Mycobacterium Infections
According to the CDC, patients exposed to contaminated water in the Terumo HX2 Heater-Cooler System may experience the following side effects:
- Unexplained fever
- Sudden weight loss
- Night sweats
- Muscle aches
- Blood in the sputum (phlegm)
Types of Heater-Cooler Systems
The Sorin Stockert LivaNova 3T, approved by the FDA in 2006, was the first heater-cooler device to market and remains the most popular heater-cooler device on the market. Other heater-cooler systems include:
Surgeries That May Include Use Of Terumo HX2 Heater-Cooler Device:
The following types of surgeries may require or include the use of the Terumo HX2 Heater-Cooler System:
- Heart valve replacement
- Heart transplant
- Lung transplant
- Coronary artery bypass graft (CABG)
- Extracorporeal membrane oxygenation (ECMO)
- Left ventricular assist device (LVAD) implant
- Aortic anomaly surgery
- Pulmonary artery banding
- Lung resection
About Terumo Cardiovascular Group
Terumo Cardiovascular Group — based in Ann Arbor, Mich. — manufactures and distributes medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring and vascular grafting. This includes a full-line of perfusion products, endoscopic vessel harvesting products and surgical stabilization products.
Terumo CV Group is the exclusive distributor of Vascutek Vascular Grafts in the United States.
The medical device manufacturer was established in 1921, and has more than 19,000 associates in 82 sales offices and 24 production facilities.
Can I File A Terumo HX2 Temperature Management System Lawsuit?
Our Terumo HX2 Temperature Management System lawyers can help if you or someone you care about contracted a severe — or possibly fatal — infection as a result of being exposed to bacteria from a contaminated heater-cooler device. Our top Terumo HX2 Temperature Management System lawyers are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Both patients and their families are seeking compensation for injuries. You may be entitled to a settlement if you were harmed by a Terumo HX2 Temperature Management System.
Our No-Fee Promise On Terumo HX2 Heater-Cooler Cases
You can afford to have our great team of Terumo HX2 Temperature Management System lawyers on your side. If you choose us, it literally costs you nothing to get started. We promise you in writing:
- No money to get started
- We pay all case costs and expenses
- No legal fees whatsoever unless you receive a heater-cooler settlement
- Phone calls are always free
How Do I Start A Terumo HX2 Temperature Management System Claim?
Our Terumo HX2 Temperature Management System case lawyers will help you file your lawsuit. To get started, you can:
- Submit the Free Case Review Box on this page, or
- Call (866) 280-3417 any time of day to tell us about your case.
We will listen to your story and answer your questions. If you have a claim, we will start immediately.
WARNING: There are strict time deadlines for filing Terumo HX2 Temperature Management System lawsuit claims.