Overview
More than 250,000 bypass procedures are completed yearly in the United States using heater-cooler devices. Heater-cooler devices provide a vital function during these operations because they help keep a patients circulating blood and organs at a specific temperature throughout the procedure.
However, new information has been released indicating that some LivaNova PLC (formerly Sorin Group Deutschland GmbH) Stockert 3T heater-cooler devices, used during many of these surgeries, might have been contaminated during manufacturing which could put patients at risk for life-threatening infections. Ultimately, around 60% of heart bypass procedures in the United States have been performed using these devices.
Purpose of Heater-Cooler Units
As previously mentioned, heater-cooler devices may be used during surgery to control a patient’s body temperature. This temperature control may lead to improved medical care and patient outcomes. The devices have water tanks that provide temperature-controlled water to heat exchangers or blankets which then provide cooling or warmth to the patients body.
Primary Concerns
- Nontuberculous mycobacteria infections (NTM) can cause serious illness and even death. These infections are being associated with the Stockert 3T systems.
- Research has indicted that the water used in these heater-cooler systems may become contaminated, resulting in bacteria being released into the air through the device’s exhaust vent. That bacteria can then come into contact with the patient. However, long delays may occur meaning several years can pass between the time the patient is exposed to the bacteria and when the infection occurs.
- Patients who have had open-heart surgery should seek medical care if they are experiencing symptoms associated with infections, such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever.
- Additionally, patients who have undergone open-heart surgery should look for signs of endocarditis, surgical site infection, abscess, bacteremia, hepatitis, renal insufficiency, splenomegaly, pancytopenia, and osteomyelitis. These are all common complications from nontuberculous mycobacteria infections and can occur up to four years after surgery.
Affected?
If someone you know has undergone open hear surgery and is suffering through complications related to the Stockert 3T heater-cooler devices, it is necessary you contact experienced attorney Frank Eidson immediately for a free case review. Contact attorney Frank Eidson, P.A. at 407-315-2764 (toll free: 888-245-2855). You may also email Frank personally at frank@frankeidson.com or visit his office at 327 N. Orange Ave, Orlando, FL, 32801.
