Contaminated Stöckert 3T Heater-Cooler Devices
It is estimated that more than 250,000 heart bypass procedures are performed in the U.S. each year utilizing heater-cooler devices during surgery. Unfortunately, the CDC and FDA have issued important health warnings to patients, physicians, and hospitals about the potential risk for patients developing a rare infection from certain heater-cooler devices used in surgeries as far back as 2012.
Problems Associated with the Stӧckert 3T Heater-Cooler System
Heater-cooler devices are considered Class II medical devices by the FDA. They are important during open heart surgery to keep a patient's blood and organs maintained at a specific temperature. It has been determined that a particular heater-cooler device may be unsafe because of contamination issues that occurred during manufacturing. New information indicates some Stӧckert 3T Heater-Cooler Systems manufactured by LivaNova PLC (formerly Sorin Group Deutschland GmbH) were defective and transmitted harmful bacteria into patients during surgery that may lead to a rare and serious infection. Available information suggests patients who had valves or prosthetic products implanted are at higher risk of these infections. Infections caused by the contaminated heater-cooler devices can be severe, difficult to diagnose, and sometimes fatal.
The particular bacteria found in the devices, mycobacterium chimaera, is a species of nontuberculous mycobacterium (NTM) typically found in soil and water. Usually, this kind of bacteria would rarely cause illness in a healthy person. However, those who have been exposed to the bacteria during an open-heart procedure can develop non-specific symptoms slowly - possibly over the course of months or up to a year - which often makes the infection difficult for physicians to diagnose. Special cultures must be performed to help diagnose and treat patients who might have been put at risk.
Information for Patients and Medical Providers
The infections caused by the contaminated heater-cooler devices can be severe or potentially fatal. The CDC has created a Health Alert Network for medical providers to help identify and inform patients who might have been put at risk and may be vulnerable to infection. The CDC and FDA strongly encourage patients who have undergone open heart surgery to seek medical care immediately for any symptoms of potential infection which may include symptoms such as:
- night sweats
- muscle aches
- weight loss
- abdominal pain
- redness at the surgical site
- unexplained fever
Tampa Defective Medical Device Lawyer
If you or a loved one have undergone open heart surgery and later developed an infection, it is important that you consult with legal counsel experienced with defective medical devices. If you have questions, do not hesitate to contact us.
Helpful Consumer Resources
Click here to view the full CDC Press Release dated 10/13/16
Click here to view Q&A for Patients from the CDC
Click here to view Q&A for medical providers from the CDC
Click here to view FDA Safety Communication from 2015
Click here to read the FDA’s Updated Safety Communication from June 2016
Click here to read the FDA’s Updated Safety Communication from October 2016
Click here to read more about heater-cooler devices