In October 2016, the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) issued warnings concerning the risk of infection associated with Stockert 3T heater-cooler units. These specialized devices are routinely used during open heart surgeries and other procedures. Federal agencies report that some of the devices may be contaminated with a bacteria that can be dangerous or fatal for heart patients. Patients should be aware of the risk and seek a medical diagnosis if they have recently undergone open heart surgery.
If you or a loved one were recently diagnosed with a bacterial infection after surgery, speak to one of our injury attorneys about your situation. You may be entitled to compensation. Call Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A. at 419-843-6663 for a free consultation.
What is the problem with Stockert 3T Heater-Cooler units?
Heater-cooler devices are an essential part of open heart surgery. More than 250,000 people under heart bypass procedures using heater-cooler devices every year, according to the CDC. Using cool water and fans, these machines help keep the patients’ blood, heart, and body at a safe, specific temperature during the procedure.
The problem is that some of the devices have been contaminated with Nontuberculous Mycobacteria (NTM) bacteria during the manufacturing process in Germany. NTM bacteria is a common organism often found in soil and tap water. They are usually harmless for healthy people, but can cause serious, life-threatening infections in patients with compromised immune systems.
“Samples of the water drained from the 3T devices and air samples collected while the devices were in operation were tested. The results strongly suggest the 3T heater-cooler units are the source of M. chimaera [a type of NTM] contamination,” reports the FDA. In contaminated devices, the fans can potentially blow the bacteria from inside the machine into the surgery room and into the patient’s body.
How do I know if I have been infected with NTM bacteria?
Roughly 60 percent of all heart bypass procedures performed use a heater-cooler device that has been associated with NTM bacterial infections. The FDA has received dozens of reports of patient infections associated with heater-cooler devices. In hospitals where at least one infection has been identified, the CDC estimates patients’ risk of getting an infection between one in 100 and one in 1,000.
Diagnosis is challenging because it can take months for the bacteria to cause symptoms. Plus, the symptoms are non-specific so neither patients nor doctors may first realize at first that the symptoms have anything to do with an NTM infection. CDC Deputy Director Dr. Michael Bell explains, “If you are a couple of years out from your surgery, and you aren’t having any symptoms, then you don’t need to worry about this particular issue.” However, if your surgery was more recent, you should go to your clinician if you are having any of the following symptoms which could be related to an NTM infection:
- Night sweats
- Redness, heat, or pus at the surgical site
- Muscle or joint pain
- Weight loss
- Nausea or vomiting
Where can I find more information about contaminated heater-cooler units?
Inform yourself of the risks of Stockert 3T heater-cooler device-related bacterial infection, and speak to your doctor if you have any concerns. Here are a few helpfuol resources with more information:
- Sample Letter for Patients to Give their Healthcare Provider
- CDC Video: Important information for heart surgery patients
- FDA Safety Communication: Infections Associated with Stӧckert 3T Heater-Cooler System
- CDC Q&A on heater-cooler device-related infections
How are NTM bacterial infections treated?
If you test positive for a NTM bacterial infection, your doctor will probably begin your treatment by giving you a round of strong antibiotics. This particular type of bacteria can be resistant to treatment, however, and some patients need prolonged treatment lasting months or even years. Although rare, some patients who contract an NTM infection after heart surgery may require additional surgery. If left untreated, NTM infection can be potentially fatal.
What remedies do patients have if they have developed a NTM infection?
Infected patients (and family members in fatal cases) have already begun filing personal injury and class action lawsuits against the manufacturer. If you have been diagnosed with an NTM infection after surgery that utilized a heater-cooler device, you may be eligible to file a claim and pursue compensation for your losses. There is strong evidence to support the link between the devices and NTM infections, so the chances of winning your case are excellent. Not only have the CDC and FDA issued warning reports on the device, but there has even been a national recall.
You may be able to recover damages for losses such as:
- Medical bills associated with the infection, both current and future
- Miscellaneous expenses related to your injuries
- Loss of wages
- Household services
- Pain and suffering
- Loss of quality of life
- Death benefits such as funeral expenses, loss of income, and loss of support (in fatal case)
How do I pursue compensation for a post-surgery NTM infection?
If you have a serious infection related to a surgery, your first step in pursuing compensation is to speak to an injury lawyer about your case. Our attorneys at Gallon, Takacs, Boissoneault & Schaffer Co., L.P.A would be happy to assist you. We will review your case, investigate the facts, and let you know if your case meets the criteria to file a liability claim.
Our firm cares deeply about our clients’ situations. We know how devastating a serious infection can be, not only physically, but for financially and emotionally. If your illness was caused my a defective device or medical mistake, we can help you hold the appropriate party liable and fight for maximum compensation on your behalf.
Contact our office today at 419-843-6663 for a free consultation to learn more.