Contaminated Heater-Coolers Pose Infection Risk for Heart Surgery Patients.
Thousands May be Owed Compensation.
More than half a million patients are at risk for serious and potentially deadly bacterial infection from some heater-cooler devices used during open chest surgeries, the CDC warns.
Many may have been contaminated with nontuberculous mycobacterium, particularly Mycobacterium chimaera, which may cause serious illness and death.
You had open heart surgery and are grateful for a second chance. After a few months you start to feel like a new person. You’re high on life because you’ve been given a new lease on it.
A year or so later you start to notice some things aren’t “quite right.” Nothing alarming. Some night sweats. Muscle and joint aches. Unexplained fatigue and fever. You go to the doctor thinking you may have been bitten by a tick.
No, she says after thorough and exhaustive testing. You have nontuberculous mycobacteria (NTM), a rare slow-growing infection that requires one to two years of extremely strong antibiotic treatment that, in itself, can leave you with a host of severe side effects.
She further offered that some heart surgery patients contracted the infection via the heater-cooler systems used during their surgery. In one hospital, she confided, nearly half those infected died.
If you have had open heart surgery or any surgery in which a Stockert 3T heater-cooler was used, you may be entitled to compensation. Click here to contact a North Carolina lawyer or call 1-866-900-7078.
The Facts About the Stockert 3T Heater-Cooler System
The device causing worldwide concern is the Stockert 3T heater-cooler system manufactured by the German company, LivaNova PLC (formerly Sorin Group Deutschland GmbH). These devices are used during open-heart procedures to heat or cool a patient’s blood as a part of their care, keeping their blood at a specific temperature during the procedure.
It looks somewhat like a small portable air conditioner and uses tubes, hoses, fans, and sterilized water to warm or cool the patient as needed during surgery. Air flows into the device where it is either warmed or cooled, and flows back out, as the FDA illustration here shows:
The CDC believes many devices were contaminated with NTM during production at the factory.
Problems with Stockert 3T Heater-Cooler Systems
One of the problems with the Stockert 3T heater-cooler system is a fundamental design flaw. The air outflow flows directly toward the patient’s open surgical cavity.
How does the air blown out of the device become infected in a “clean room,” which surgical operating rooms are required to be?
Biological evidence “strongly suggests” that many of the machines were contaminated with NTM during production in a German plant.
What is Nontuberculous Mycobacteria (NTM)?
Nontuberculous mycobacteria is a slow-growing bacteria that is found everywhere – in the water and in our soil – and is usually harmless. That is, unless you inhale it into your lungs or it enters your bloodstream through an open wound, such as during surgery, or your immune system is compromised, such as after surgery. While it is rare to contract NTM during surgery, many surgery patients have become infected in recent years.
Signs of NTM Infection
What makes the wide-spread potential for infection so difficult to assess is that NTM is slow growing and symptoms can take months to years to present. Nevertheless, if you have had heart surgery where a heater-cooler system was used, be mindful that you could be at risk, and you should have received a letter from the surgical facility that performed your procedure.
Serious symptoms of possible infection include:
Other symptoms to look for:
Stockert 3T Heater-Cooler Recalls
In July 2015 Sorin/Liva Nova recalled more than 1,700 Sorin Stockert 3T, 120V/60 Hz heater- coolers because of contamination “if proper disinfection maintenance is not performed per instructions for use.”
Sorin Group issued letters to affected hospitals advising them to maintain-heater coolers according to the instructions.
FDA Warnings – Too Little Too Late?
In 2010, the FDA began receiving reports of infections linked to heater-cooler machines. Yet, it took the manufacturer until June 2015 to issue a recall alert. During that time thousands of heart patients were unwittingly exposed and vulnerable to the potentially deadly nontuberculous mycobacteria during their surgeries.
The FDA posted a recall notice of the device.
October 15, 2015
The FDA issued a Nontuberculous Mycobacterium Infections Associated with Heater-Cooler Devices – Safety Communication to provide recommendations to minimize patient exposure.
June 1, 2016
The FDA updated its Safety Communication to provide new information about Mycobacterium chimaera (a form of NTM) infections associated with the use of the Stockert 3T in U.S. patients who have undergone cardiothoracic surgeries. This communication also contained updates to help prevent the spread of infection related to the use of these devices.
October 13, 2016
The FDA issued another updated Safety Communication on Mycobacterium chimaera infections associated with the Stockert 3T Heater-Cooler System. That same day the Centers for Disease Control (CDC) issued a press release urging hospitals to take action, and advising patients to seek care if they feel ill.
Stockert 3T Heater-Cooler Lawsuit
Patients with compensable claims should be paid for:
- Additional surgeries required as a result of the infection
- Hospital stay and any medical bills
- Time out of work
- Pain and suffering
- Other associated damages
North Carolina Lawyers Offer FREE Case Evaluation
If you or someone you know had heart surgery, and a Stockert 3T heater-cooler was used, and any of the symptoms mentioned developed, contact your doctor right away for treatment.
Then contact us if your doctor diagnosed you with nontuberculous mycobacteria (NTM). You could be eligible for compensation for damages incurred as a result of manufacturer negligence.
Click here to report your claim to one of our North Carolina lawyers or call us 24/7 at 1-866-900-7078.