Stockert 3T Heater-Cooler
If you or one of your loved ones developed an infection after open-chest surgery and other cardiopulmonary operations then you may be able to file a lawsuit if the Stockert 3T heater-cooler was used during the procedure. You may be at risk for contamination by Mycobacterium chimaera that may have grown out of the device’s water tanks which may have lead you to contract Nontuberculous mycobacterium (NTM).
The Stockert 3T is a medical device used during surgeries to regulate a patient’s body temperature to improve the patient’s well-being and medical care. The Stockert 3T has water tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. The Stockert 3T was manufactured by a German company called LivaNova (formally Sorin Group) and was approved by the FDA in 2006.
One of the reasons why this is such a significant health issue is because there were approximately a quarter of a million such surgeries performed last year in the United States and not only that, but approximately 60% of the heater-cooler devices currently in use in United States hospitals were manufactured by LivaNova.
Since the discovery of these infections from this bacterium the FDA and CDC have issued several documents on the 3T Stockert. In July of 2015 the FDA issued a recall of the Stockert 3T and stated that the medical device was associated with a “potential colonization of organisms, including Mycobacteria”. In October of 2015 both the FDA and the CDC issued similar safety warnings about the risk of Mycobacteria in the Stockert 3T and “a need for increased vigilance for NTM infections” that was associated with the heater-cooler device.
The Pennsylvania Department of Health also issued a warning in regard to the risk of NTM infections to patients undergoing open-heart surgery and other cardiopulmonary operations. In October of 2016 the FDA issued another warning on how to prevent further infections.
The CDC has asked hospitals to send a letter to any patient who has had such a surgery. The symptoms which a patient should be alerted to are:
- Night sweats
- Muscle aches
- Weight loss
- Difficulty breathing
- Unexplained fever
- Persistent cough or cough with blood
- In infants, a failure to grow or gain weight
It is important to note that even though this infection is very serious indeed, it cannot be spread from one person to another.
If you have received such a letter from your hospital or surgeon, or if you have been diagnosed with an NTM infection after cardiac surgery, we would be glad to discuss this with you.Do I have a case? Free Case Evaluation