Some heart surgery patients may be at risk of contracting a potentially deadly infection due to LivaNova’s Stockert 3T Heater-Cooler system, which may have been contaminated during its manufacturing, government health officials warn.
The Centers for Disease Control and Prevention (CDC) issued the recent warning to healthcare providers and patients, alerting them that Stockert 3T Heater-Cooler system commonly used in open-heart surgeries may have been contaminated.
The Stockert 3T Heater-Cooler system and other cardiac heater-cooler units are an essential part of these life-saving surgeries because they help keep a patient’s circulating blood and organs at a specific temperature during the procedures, according to the CDC.
The warning was issued following a Consumer Reports article outlining the risk and stating concern that patients were not being told about it.
Heart Surgery Patients Cautioned On Stockert 3T Heater-Cooler System
The CDC said its advisory was issued after the agency received “new information” about the LivaNova Stockert 3T Heater-Cooler system.
From Jan. 1, 2010, to Feb. 29, 2016, the U.S. Food and Drug Administration (FDA) received 180 incident reports related to cardiac heater-cooler devices around the world. The reports include 16 U.S. hospitals in 10 states where at least 45 patients were infected, and at least nine died.
According to the CDC, approximately 60 percent of the 250,000 heart-bypass procedures performed in the U.S. each year utilize the device.
The CDC warns open heart surgery patients to be aware of the following symptoms and seek medical care:
- Night sweats
- Muscle aches
- Weight loss
- Fatigue
- Unexplained fever
CDC officials also warned that infection symptoms could take months to develop, and therefore infections could be missed or delayed – sometimes for years – making them more difficult to treat.
“It’s important for clinicians and their patients to be aware of this risk so that patients can be evaluated and treated quickly,” said Dr. Michael Bell, deputy director of CDC’s Division of Healthcare Quality Promotion, in a press release. “Hospitals should check to see which type of heater-coolers are in use, ensure that they’re maintained according to the latest manufacturer instructions, and alert affected patients and the clinicians who care for them.”
He also called upon hospitals to “check to see which type of heater-coolers are in use, ensure that they’re maintained according to the latest manufacturer instructions, and also alert affected patients and the clinicians who care for them.”
Were You Harmed by a Cardiac-Heater Cooler?
If you suffered an infection or other injury after undergoing surgery in which a LivaNova Stockert 3T Heater-Cooler system or other cardiac heater-cooler device was used, you should contact an experienced attorney immediately. You may be entitled to compensation by filing a lawsuit against the manufacturer.
Do YOU have a legal claim? Fill out the form on this page now for a free, immediate, and confidential case evaluation. The hip implant attorneys who work with Top Class Actions will contact you if you qualify to let you know if an individual lawsuit or class action lawsuit is best for you. [In general, metal hip implant lawsuits are filed individually by each plaintiff and are not class actions.] Hurry — statutes of limitations may apply.
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