Cincinnati Sub-Zero Hemotherm CE & 333W: Bacteria Infection Lawsuits
Cincinnati Sub-Zero, a self-described leader in blood temperature management solutions, is reportedly catching heat for its controversial heater-cooler system.
The Hemotherm CE, a cardiovascular heater-cooler device, is management device used to control blood temperature during cardiopulmonary by-pass and other related cardiovascular procedures. However, the medical device has recently been linked to mycobacteria, a harmful bacteria that can pose a risk of infecting patients, through indirect contact.
The system, supplies water to a blood temperature exchanger/oxygenator or hyper-hypothermia blanket, can reportedly transmit bacteria through the air and through the device’s exhaust vent into the environment and to the patient, if contaminated.
Cincinnati Sub-Zero Hemotherm CE & 333W Linked To Bacterial Infection
The U.S. Food and Drug Administration recently issued a Medical Device Safety Communication regarding Nontuberculous Mycobacterium (NTM) Infections associated with heater-cooler devices, such as the Cincinnati Sub-Zero Hemotherm CE and 333W, to heighten awareness about infections associated with heater-cooler devices.
In response to the FDA’s warning, Cincinnati Sub-Zero issued a release in November 2015, stating the medical device company has received “no reported incidents associated with NTM contamination or infection involving CSZ’s cooler-heater devices.
“However, there is one known reported bacterial contamination related to Cupriavidus Pauculus/R. Paucula, which is widely found in hospitals, associated with an ECMO Heater,” the company said. “An investigation of this 2009 incident determined it may have resulted from a failure to follow the device’s cleaning procedures. It is incumbent on all hospitals and clinics to develop and maintain an adequate infection control plan at all levels to produce the greatest level of patient safety from nosocomial infections.”
A year after the FDA’s initial alert, the CDC issued a release warning healthcare providers and patients about the potential risk of infection from heater-cooler 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.
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 Cincinnati Sub-Zero Hemotherm CE & 333W:
The following types of surgeries may require or include the use of the Cincinnati Sub-Zero Hemotherm CE and 333W Heater-Cooler Systems:
- 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 Cincinnati Sub-Zero
Cincinnati Sub-Zero — a subsidiary of Gentherm, the global market leader and developer of innovative thermal management technologies — is based in Sharonville, Ohio and comprised of three divisions: medical, industrial and CSZ testing services.
Gentherm — a technology company with a focus on thermal technology — has locations in 12 countries, and more than 10,000 employees worldwide. The technology company designs, develops and manufactures heating, cooling, and ventilating devices, including:
- Heated and cooled seating
- Heated steering wheels
- Heated and cooled cup holder
- Cool bin
- Interior surfaces
Can I File A Cincinnati Sub-Zero Hemotherm CE & 333W Heater-Cooler Lawsuit?
Our Cincinnati Sub-Zero Hemotherm CE and 333W Heater-Cooler case 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 heater-cooler 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 Cincinnati Sub-Zero Hemotherm CE and 333W Heater-Cooler System.
Our No-Fee Promise On Cincinnati Sub-Zero Hemotherm CE and 333W Cases
You can afford to have our great team of Cincinnati Sub-Zero Hemotherm CE and 333W Heater-Cooler lawyers on your side. If you choose us, it 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 Cincinnati Sub-Zero Hemotherm CE and 333W Heater-Cooler Claim?
Our Cincinnati Sub-Zero Hemotherm CE and 333W Heater-Cooler 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 Cincinnati Sub-Zero Hemotherm CE and 333W Heater-Cooler System lawsuit claims.