New warnings from the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) are being issued to patients and medical facilities who have undergone or performed cardiothoracic surgery. Due to a contaminated water source during equipment manufacturing, these individuals have been exposed to dangerous bacteria and are at risk of developing a potentially deadly infection.
The LinaNova PLC (formerly Sorin Group Deutschland GmbH) Stockert 3T heater-cooler device is used during open heart surgery to distribute water for temperature regulation and control and is a vital part of surgery success. However, facilities that use these devices are being advised to discontinue their use immediately and caution patients who may have been exposed to monitor their health for any signs of infection.
Mycobacterium chimaera (M. chimaera) is a nontuberculous mycobacterium that causes a severe and often fatal infection. M. chimaera is considered a slow growing bacteria that is not detected for months or even years after exposure. A European study tested the water used in the facility where the Stockert 3T heater-cooler device is manufactured and found M. chimaera present.
Later research shows that the manufacturer has successfully made the necessary sanitation changes, but this action only effects units made after September 2014. Patients at risk are encouraged by CDC to report any signs of infection such as night sweats, muscle aches, weight loss, fatigue, or unexplained fever to their medical care provider immediately.
Healthcare facilities with Stockert 3T devices have been warned by the FDA to discontinue use of this equipment immediately and replace all tubing and surrounding equipment that may have also been contaminated. While in use, the water in the device releases a vapor into the air that could expose not only the patient, but also the medical staff performing the surgery to the dangerous bacteria. All individuals involved are encouraged by the FDA to continue to closely monitor their health.
Infection as a result of the use of the Stockert 3T device is rare but should not be taken lightly. Every year in the United States alone more than 250,000 open heart surgeries are performed. Approximately 60% of those surgeries use the Stockert 3T heater-cooler device. An exposed individual’s risk of developing infection is between 1 in 100 and 1 in 1000. Patients who had valve replacement or prosthetic products implanted during surgery are at a greater risk for developing an infection.
If you wish to learn more about the contaminated Stockert 3T heater-cooler device or as a result of cardiothoracic surgery have potentially been exposed to M. chimaera bacteria, contact Thomas Law Offices for more information or to receive a zero-obligation case consultation. Tad Thomas, Louisville, KY medical malpractice lawyer, and his team are dedicated to helping their clients – and all of Kentucky – receive safe and responsible medical care.