The invention of the cardiopulmonary bypass machine, a device that allows the heart to be stopped while maintaining circulation to the rest of the patient’s body and brain, began a revolution in medicine in the 1950’s. For the first time, surgeons could stop a beating heart while keeping the patient alive, allowing new surgical techniques to be developed that have since saved millions of lives. Open-heart procedures are not easy, though, and require the complex coordinated work of surgeons, anesthesiologists, nurses, technicians, and other allied health personnel all functioning in conjunction with cutting-edge medical devices. Sometimes, though, these medical devices can cause unforeseen and devastating complications to patients.
Heater-Cooler Device Linked to Infections
During modern open-heart procedures, a device called a heater-cooler unit is used to adjust and maintain the temperature of the patient’s body and circulatory system. This allows the surgical team much greater control over the procedure, which can increase survivability and lead to better patient outcomes. But recently, news has come out that one particular machine, the Stockert 3T Heater-Cooler System, may be the source of life-threatening post-operative infections.
The Stockert 3T Heater-Cooler System was originally developed by the Sorin Group (now known as LivaNova, after merging with another company) and is sometimes called the Sorin 3T Heater-Cooler System. The U.S. Food and Drug Administration first raised the alarm in 2015 about the Stockert 3T’s association with certain kinds of infections, and the Centers for Disease Control and Prevention (CDC) followed suit. In 2016, both agencies then issued further warnings about the potential risk for infection with the device, and in October the CDC released this report about heater-cooler units.
Currently, the issue seems to be that the water tanks these devices use can harbor a dangerous strain of mycobacteria, called M. chimaera. Though the water does not come into contact with the patient, the contaminated water may evaporate, carrying the bacteria through the air and depositing it on otherwise sterile equipment, or even directly into the surgical site itself. The bacteria, once it has infected the patient, can take a long time to cause any symptoms of infection—months, or even years, may pass before the patient is aware that he or she is sick.
Some of the possible signs of infection by M. chimaera after an open-heart surgery include:
- Surgical site redness, heat, swelling, or pus
- Prolonged and unexplained fevers
- Nausea and vomiting
- Trouble breathing
- Lack of energy
- Night sweats
- Joint pain
- Coughing or bloody cough
In addition, infants who have the infection after surgery may be unable to put on weight or grow appropriately with their age.
Whether young or old, infection by this bacterium is extremely dangerous and difficult to treat. It’s typically rare, so many doctors may not know to look for it, particularly when the symptoms are so delayed in onset. Treatment options usually involve multiple rounds of highly potent antibiotics, which come with their own set of risks and health concerns. The mortality rate of M. chimaera is staggeringly high, approaching 50 percent in some cases.
Patients who have suffered harm as a result of this potentially lethal infection are beginning to look for relief by filing personal injury lawsuits against the manufacturer of the Stockert 3T unit, as well as against the hospitals themselves. Evidence provided by the CDC indicates that the bacteria were found in samples provided by the company directly from their German manufacturing plant, but the bacteria may also be found in the hospital environment.
Distraught families have also begun to file wrongful death lawsuits against the manufacturer and hospitals, seeking redress for their lost loved ones. At least four patients are known to have died so far, and nobody knows how many more may be at risk.
Get Legal Assistance Today
If you think you’ve been harmed or have lost a loved one due to this highly dangerous and deadly infection, you may have legal options to pursue compensation in a court of law, and Wayne Wright LLP would like to hear from you. We make it our business to help patients and families who have been hurt by dangerous or defective medical devices receive the financial compensation that they deserve for their pain, suffering, and loss. To arrange a free, no-obligation evaluation of your potential compensation claim, call us today at 800-237-3334.