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Goza & Honnold Handling LivaNova 3T Heater-Cooler Device Cases

Infection Cases Occurring At The University of Kansas Medical Center

The defective medical device attorneys at Goza & Honnold are currently investigating claims involving the LivaNova 3T heater-cooler device used in patients undergoing surgery at The University of Kansas Medical Center.  The use of this device during cardiac surgery can lead to serious and life-threatening infections. If you or a loved one developed an infection following cardiac surgery that took place at The University of Kansas Medical Center, contact our office. We can review your medical records to see if a 3T heater-cooler device was used and evaluate whether you have a potential claim for damages. 

What is a heater-cooler device?

During cardiac surgery, the surgical team stops the patient’s heart in order to perform the operation effectively. The team then uses machines to continue the patient’s blood flow, one of which is typically a heater-cooler device. This device is designed to keep the patient’s blood at the proper temperature using temperature-controlled water tanks hooked to an external heat exchanger. The patient’s blood is then pumped into the heat exchanger to regulate the blood’s temperature. 

A heater-cooler system is designed to be closed, meaning the patient should not come in contact with the water inside the device. However, in the LivaNova 3T heater-cooler, the water inside the tanks can turn into a vapor that is released into the operating room by way of the device’s exhaust fan. Bacteria present in the water and water vapor can then contaminate the operating room air and travel into the patient’s open surgical site, resulting in severe infection. Many such infections occurred from cardiac procedures performed at The University of Kansas Medical Center from 2018 to 2020.   

What injuries can occur from a 3T heater-cooler infection?

Bacteria known by the name Mycobacterium chimaera (M. chimaera) is specifically linked to LivaNova 3T heater-cooler devices. This bacteria can lead to severe infections in patients, necessitating additional surgeries, prolonged hospitalizations, and heavy antibiotic treatments. Signs of a 3T device-associated infection can include:

  • Fever
  • Fatigue
  • Muscle aches
  • Unexplained weight loss
  • Chills 
  • Night sweats
  • Apparent infection of the surgical wound

An M. chimaera infection can often be life-threatening or cause permanent injuries, so it is vital that patients receive immediate care for any signs or symptoms following cardiac surgery. 

How do I know if a 3T heater-cooler was used during my surgery?

Surgeons and surgical staff rarely tell patients about every piece of equipment used during their cardiac procedures. However, they keep a log of that equipment, which should be located in the patient’s medical records. You might have also received a letter from The University of Kansas Medical Center advising you about the use of the LivaNova product during your surgery.

Goza & Honnold’s LivaNova 3T heater-cooler attorneys can order your medical records and pinpoint whether a heater-cooler device was used during your surgery and whether the device was the 3T brand manufactured by LivaNova. 

Has there been a recall of the 3T heater-cooler?

At this time, the 3T heater-cooler is still on the market. However, the U.S. Food and Drug Administration (FDA) required new instructions for use of the device after learning about the propensity for patient infections. The FDA has also continually provided updated guidance for cleaning and maintaining the device in order to avoid infection and has urged health care providers to upgrade their 3T heater-coolers to newer models. 

Even with new guidance from the FDA, ongoing studies suggest the only way to safely use the 3T device is to keep it outside of the operating room. Hospitals and surgical facilities that have failed to upgrade their systems or follow proper precautions could be held accountable for patient infections and resulting injuries. Goza & Honnold is currently filing 3T heater-cooler infection cases against both LivaNova and The University of Kansas Medical Center.

Contact the LivaNova 3T Heater-Cooler Attorneys at Goza & Honnold Today

If you or a loved one underwent cardiac surgery and developed a serious postoperative infection, contact Goza & Honnold today. You can arrange a free case consultation with one of our experienced attorneys by calling (913) 451-3433 or by using our online contact form.