The Sorin 3T Surgical Device: Contamination and Crisis
Over the past few years, serious infections linked to heater-cooler surgical devices that are often used in cardiothoracic surgery have become a growing problem. The heater-cooler devices, which keep patients more comfortable during major surgery, especially open-heart or open-chest procedures, can have their drawbacks, though. Recently the Stӧckert 3T Heater-Cooler System made by LivaNova PLC (formerly Sorin Group Deutschland GmbH) has been spotlighted for a problem you might not expect: contamination that arises from the manufacturing source, not your local operating room.
What Are Heater-Cooler Surgical Devices?
Surgical devices such as the LivaNova/Sorin 3T are called “heater-cooler” because they vary the temperatures needed to keep a surgical patient in optimal condition during major surgery such as the opening of the chest area. Heater-cooler devices, or HCDs, can provide temperature-controlled water to heat exchangers for oxygenators, can be cardioplegia (heart paralysis) heat exchangers, or can be blankets to warm or cool a patient undergoing cardiopulmonary bypass surgeries that last six hours or less.
Unfortunately, HCDs have become implicated in a growing number of cases of nontuberculous mycobacterium (NTM), where airborne bacteria have invaded the sterile surgical field and caused infections. The mycobacteria in question, Mycobacterium chimera and Mycobacterium abscessus, have been confirmed as coming from the LivaNova/Sorin 3T’s manufacturing location in Germany. It’s entirely possible that the bacteria in question have arisen from the testing process, as Sorin tested devices with water and then shipped them out while they were still wet. Wet locations are often friendly to bacterial multiplication.
But when mycobacteria invade a surgical site, it’s a different matter altogether. Because they grow very slowly, taking at least two to eight weeks to show up in detectable numbers, identifying the microbes requires sequencing that only a few U.S. laboratories perform. Dr. Keith B. Allen of St. Luke’s Mid American Heart Institute and the University of Missouri–Kansas City is the lead author of a study that is concentrating on the problem. Dr. Allen has been quoted as saying, in reference to the slow growth of the mycobacterium, “We are just beginning to scratch the surface, even though this research has been going on for more than 2 years.” He also added, “This is a device problem, not a surgical problem.”
What is the FDA Doing?
On June 1, 2016, the FDA issued a safety communication for Mycobacterium chimera and the Sorin 3T heater-cooler devices. Initially the problem was thought to be limited to devices manufactured before September, 2014. However, although the maker of the Sorin 3T added new disinfection and cleaning procedures in September, 2014, some 3T devices manufactured after that time have tested positive for M. chimera.
Some believe the FDA waited too long to sound the alarm about the risks of the heater-coolers. It’s been acknowledged by federal regulators that the agency knew about infections tied to these devices by the summer of 2014. And yet the FDA waited until October, 2015, to issue a public alert. And it was not until October of 2016 that they supplied both patients and hospitals with recommendations that indicated what they should do.
Is There a Local Problem in SC?
Up to 3,000 patients may have been exposed to dangerous mycobacterium since 2012 at the Medical University of South Carolina (MUSC) during open-heart surgeries. In January, 2017, MUSC stated that, while no evidence exists that anyone has become infected, they are following guidelines issued by the federal government to notify patients about the possible hazards.
Hospitals are wise to be cautious. At Greenville Memorial Hospital during 2014, 15 patients were infected by a Mycobacterium abscessus outbreak. Four of them died.
An Ongoing SC Court Case
Because the heater-cooler mycobacterium issue is relatively new, few cases are underway. But there is one case in South Carolina. A husband and wife who live in Anderson County have brought a suit against LivaNova PLC for the husband’s exposure to non-tubercular mycobacterium during an aortic valve replacement procedure that he underwent at the Greenville Health System Hospital. The Sorin 3T heater-cooler was used during the surgery.
Have you or a loved one recently undergone major surgery where a heater-cooler device was employed? If you have developed symptoms you can’t explain, including fever, weight loss, night sweats, fatigue, and muscle aches after such surgery, especially after open-chest surgery, we urge you to see your doctor to be diagnosed and treated. If you have developed a post-surgical infection due to a non-tubercular mycobacterium (NTM) and you have suffered complications after such an operation, you might consider seeking legal assistance.
When life goes wrong, we fight for what’s right.
If you believe you have suffered surgical complications resulting in an injury due to the Sorin 3-T or other heater-cooler surgical device, the defective medical device lawyers of the Louthian Law Firm in South Carolina can help you obtain compensation for your injuries, pain and suffering. You can also pursue remuneration for medical expenses, rehabilitation, loss of income, and reduced quality of life. We will investigate every aspect of the product’s development and application to make sure all appropriate defendants are named in the lawsuit. This could include the laboratory which failed to conduct adequate pre-market testing; the manufacturer who failed to maintain quality control; the doctor or hospital which failed to warn of possible complications or give adequate instructions; as well as others whose negligence contributed to your injury.
We’ll fight for your right to safe and appropriate medical care with discipline, diligence and dedication. For a free consultation, call us today at 1-803-454-1200, or use our confidential online form.