The U.S. Food and Drug Administration (FDA) has issued an updated safety notice regarding infections caused by the LivaNova PLC Stӧckert 3T Heater-Cooler System, formerly known as the Sorin Group Deutschland GmbH system. Patients have suffered harm from infections caused by the 3T heater-cooler system.
If you have been harmed by this defective medical device or another dangerous medical device, contact our nationwide product liability attorneys at (504) 587-1440 or 1-800-587-1889 for a free case evaluation.
Risk of Serious Infections from Use of Medical Device
In its October 13, 2016, safety communication, the FDA again warns of the potential for patients to contract Mycobacterium chimaera (M. chimaera) infections. The machine is used in cardiothoracic surgeries and other types of surgery.
The device assists in cooling or warming a patient by providing temperature controlled water to warming/cooling blankets or external heat exchangers. The water is contained in closed circuits; however, there is a potential for the water to enter other parts of the machine. The bacteria can then enter the air causing the patient to contract the infection.
A European study found a link between the M. chimaera infection and the use of the 3T Heater-Cooler system. Even though the FDA believes M. chimaera infections are rare when using the 3T system, it does believe that healthcare providers and patients should take additional precautions.
Updated Recommendations for The Use of 3T Heater-Cooler
As the FDA continues to investigate this matter, it believes that healthcare facilities should use extra precautions when using the 3T Heater-Cooler. The updated recommendations for health care facilities and staff are contained in its updated safety communication. The information is detailed and divided into sections applicable to all 3T devices in addition to devices manufactured prior to and after September 2014.
The communication also contains information for patients including a list of the possible signs and symptoms of NTM infection. Symptoms may include:
- Fever
- Muscle and/or joint pain
- Fatigue
- Pain
- Night sweats
- Heat, redness, or pus at the surgical site
- Vomiting and/or nausea
- Abdominal pain
- Weight loss
Any patient suffering from the above symptoms or any changes in general health after a cardiopulmonary bypass procedure should contact their physician immediately. Additional information for patients is provided on the FDA’s Heater-Cooler device page.
Hold Manufacturers and Healthcare Providers Responsible for Injuries
If a medical device injures you, you may be entitled to recover compensation from one or more parties. To determine who is responsible, you need an experienced defective medical device attorney to conduct a thorough investigation. Multiple defective medical devices are the subject of lawsuits each year in the United States.
Injured patients deserve to be compensated for their damages, including medical bills, lost wages, emotional stress, and physical pain. In the event a medical device causes death, the family has the right to sue the responsible party for compensation for the wrongful death of their loved one.
If you have questions or you believe you have a claim, contact Attorney Fred Olinde of The Olinde Firm by calling (504) 587-1440 or 1-800-587-1889 to request a free consultation. We represent clients in Louisiana and throughout the United States.