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Heater-Cooler Lawsuit

The FDA has warned that heater-cooler devices used during open-heart surgery and other medical procedures may transmit bacteria and cause infections resulting in severe injury or death.

The U.S. Food & Drug Administration (FDA) has warned that heater-cooler devices used during open-heart surgery and other medical procedures may transmit bacteria and cause infections resulting in severe injury or death.

Free Confidential Lawsuit Evaluation: If you suffered an infection or other injury after undergoing surgery in which a heater-cooler device was used, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer and our lawyers can help.

Update: Pennsylvania Man Alleges M. Chimaera Infection from Stӧckert 3T heater-cooler

October 4, 2017 – A married couple from Hanover, Pennsylvania, has filed suit against LivaNova, claiming that its Stӧckert 3T heater-cooler caused the man to develop a life-threatening M. Chimaera infection. The complaint names both LivaNova Deutschland GMBH and Sorin Group USA Inc., as defendants, bringing claims of negligence, design defects and other damages.

Overview

Heater-cooler systems are used during cardiothoracic surgery and other medical procedures to warm or cool a patient in order to optimize care and improve outcomes. The devices feature water tanks that transport temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits.

What’s the Problem?

Although the water transported though the heater-cooler does not come into direct contact with the patient, there is a potential for contaminated water to enter other parts of the device or transmit bacteria through the air via its exhaust vent and onto the patient, resulting in a life-threatening infection. Learn more about the problems with heater-cooler devices on our heater-cooler FAQ page.

FDA Warning

On October 15, 2015, FDA issued a Safety Communication which stated that heater-cooler systems have been linked to severe infections, especially in patients undergoing cardiothoracic surgery. The agency’s warning came in response to at least 32 adverse event reports of infections linked to the devices from January 2010 to August 2015.

“We are aware that the use of heater-cooler devices has been associated with Nontuberculous Mycobacteria (NTM) infections, primarily in patients undergoing cardiothoracic surgical procedure,” FDA said. “NTM organisms are widespread in nature and can be found in soil and water, including tap water sources. They are typically not harmful, but in rare cases may cause infections in very ill patients and/or in individuals with compromised immune systems.”

Bacterial Infection Suspected in 4 Deaths at Pennsylvania Hospital

Just weeks after the FDA issued the warning, WellSpan York Hospital in York, PA, told about 1,300 open-heart surgery patients they may have been exposed to bacterial infections after identifying at least 8 patients at the facility who contracted NTM. Four of those patients died from resulting complications, according to CNN.

The CDC stopped short of saying the deaths were directly caused by NTM, as all 4 patients had underlying medical conditions. However, the hospital acknowledged that the infection was likely a contributing factor in the fatalities.

“The safety, health and well-being of our patients is always our highest priority,” said Keith Noll, senior vice president of WellSpan Health and president of WellSpan York Hospital. “That is why we took this very seriously and immediately notified state and federal health officials and requested their assistance and guidance.”

1,300 York Hospital Patients May Have Been Exposed to Deadly Bacteria: FOX News Video

What is Nontuberculous Mycobacterium (NTM)?

Nontuberculous mycobacteria are naturally-occurring organisms found in water and soil, according to the American Lung Association. Like tuberculosis (TB), nontuberculous mycobacteria infections affect the lungs. Each year in the U.S., approximately 2 people per 100,000 develop NTM infections caused by these lesser-known “cousins” of TB and leprosy.

Symptoms

Nontuberculous mycobacteria infections are often difficult to diagnose because the bacteria is slow-growing, and can take months or even years before signs of the infection to appear. When they do present, symptoms may include:

  • Fever
  • Weight loss
  • Cough
  • Lack of appetite
  • Night sweats
  • Blood in the sputum (phlegm)
  • Loss of energy

Outbreak of Bacterial Infections Linked to Heater-Cooler Use in New Orleans Hospital

September 13, 2017 – A number of heart surgery patients treated with heater-cooler devices at Children’s Hospital in New Orleans, Louisiana, have developed a rare bacterial infection known as Mycobacterium abscessus. Affected patients underwent surgery from late May 2017 to July 2017, according to a letter from the hospital.

Iowa Woman Files Class Action Over Heater-Cooler Infection

August 11, 2017 – A woman from Iowa who underwent heart surgery with a Stӧckert 3T heater-cooler device has filed a class action lawsuit against the manufacturers for allegedly exposing her to life-threatening bacteria. The new complaint seeks class action status for more than 4,100 plaintiffs who are or were citizens of Iowa at the time of their alleged exposure. The class members’ claims total more than $5 million.

Heater-Cooler Machines Contaminated at German Plant, Study Finds

July 15, 2017 – Contamination at a German factory that makes heater-cooler devices is the likely source of a global outbreak of deadly infections tied to the devices, a new study has found. Researchers using whole-genome sequencing matched the DNA of samples taken from contaminated heart surgery patients in several countries to samples from heater-cooler units in multiple hospitals and at the production site.

Study Finds Over One-Third of Heater-Coolers Contaminated

July 6, 2017 – A new study suggests that more than one-third of Stӧckert 3T heater-cooler devices may be contaminated with harmful bacteria such as M. Chimaera, legionella and Nontuberculous mycobacteria (NTM). The results of the study were presented at the 44th Annual Conference of the Association of Professionals in Infection Control and Epidemiology (APIC).

FDA Working with Specialists to Minimize Risk of Heater-Cooler Infections

June 6, 2017 – FDA recently issued an update on its ongoing investigation into severe NTM infections linked to to heater-cooler units used during certain open-heart and transplant surgeries. The agency reports that it is collaborating with “professional societies, public health partners, heater-cooler manufacturers, and experts to evaluate additional strategies for mitigating infections associated with heater-cooler devices.”

Illinois Man Alleges Sternal Wound Infection from Stockert 3T Heater-Cooler

April 19, 2017 – A man who claims he developed a sternal wound infection after having open-heart surgery with a Sorin Stӧckert 3T heater-cooler device has filed a products liability lawsuit against LivaNova PLC in the U.S. District Court for the District of Illinois. Plaintiff alleges that the manufacturers failed to adequately warn about the risk of contamination from the heater-coolers, and that they intentionally withheld information in order to maximize profits.

Heater-Cooler MDL Rejected

April 10, 2017 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ruled that federal lawsuits alleging infections and other injuries from Sorin Stӧckert 3T heater-cooler systems will not be centralized for pretrial handling. The panel stated that South Carolina’s 3T Heater-Cooler docket is already undergoing successful informal coordination, and that none of the parties to lawsuits filed outside of South Carolina supported the MDL.

LivaNova Objects to Heater-Cooler MDL

March 24, 2017 – LivaNova has filed a petition with the JPML opposing consolidation of lawsuits alleging infections from Stӧckert 3T heater-cooler units, saying it would not “promote the just and efficient conduct of these actions.” The company argues that consolidation is inappropriate due to specific issues in each case regarding hospitals, bacteria and patients.

LA County Heart Surgery Patients Infected After Cardiac Surgery with Heater-Cooler

February 8, 2017 – At least 3 patients in Los Angeles County who underwent open chest cardiac surgery with Stӧckert 3T heater-coolers have developed an NTM infection. Health officials have talked to 24 hospitals in the area that use the device, and are concerned that additional infections have gone undiagnosed, according to the LA Times.

Multi-Plaintiff Lawsuit Filed Against York Hospital Over Heart Surgery Infections

January 24, 2017 – Twelve patients and nine of their spouses have filed a lawsuit against WellSpan York hospital in Pennsylvania for alleged exposing them to a severe bacterial infection when they used heater-cooler machines during open-heart surgery. While the plaintiffs have not been diagnosed with NTM infection, the lawsuit states how each has developed symptoms of the infection, including night sweats, fatigue and weight loss.

Iowa Widow Files Stockert 3T Heater-Cooler Lawsuit

January 19, 2017 – The widow of a man who allegedly died from an infection related to the use of a Stockert 3T heater-cooler device has filed a products liability lawsuit against the manufacturer in the Southern District of Iowa. The complaint alleges that the 3T Heater-Cooler system was the source of a deadly M. Chimaera infection the plaintiff developed after undergoing open-heart surgery with one of the devices.

Indiana Hospitals Warn Heart Surgery Patients About Risk of Heater-Cooler Infections

January 3, 2017 – Several Indiana hospitals are warning thousands of open heart surgery patients about a risk of NTM infection linked to heater-cooler systems used during the procedure. Franciscan Health sent letters to 800 patients at its hospitals in Indianapolis, Crown Point and Lafayette who were treated with Stöckert 3T heater-coolers. Community Health Network notified about 600 patients of Community Heart and Vascular Hospital, and the Richard L. Roudebush VA Medical Center contacted 430 patients.

Bacterial Infections in Heart Surgery Patients Linked to LivaNova Heater-Coolers

October 14, 2016 – More than 500,000 patients in the U.S. who had open-heart surgery involving the use of a LivaNova heater-cooler device since 2012 could be at risk for a deadly bacterial infection, according to an FDA Safety Communication issued Thursday. Over the past year, at least 28 NTM infections in patients undergoing open-heart surgery in U.S. hospitals have been linked to the devices. Infections have also been reported in Europe, with some patients diagnosed nearly 4 years after surgery.

Pennsylvania Heart Patients Diagnosed with NTM Infections

September 21, 2016 – Three patients who recently had open heart surgery with a heater-cooler device at Penn Presbyterian Medical Center have developed NTM infections. Another patient tested positive for the bacteria but showed no sign of infection, according to Patrick J. Brennan, chief medical officer of the University of Pennsylvania health system. Three of the 4 patients remain under medical care at Penn Presbyterian and are “doing well,” while the 4th was treated at another hospital.

Iowa Hospital Warns of Infection Risk for Open Heart Surgery Patients

August 29, 2016 – About 2,600 patients who had open heart surgery with a heater-cooler device at Mercy Medical Center in Des Moines, Iowa, from 2012 to 2015 are being alerted that they might have been exposed to a bacterial infection, according to the Des Moines Register. Hospital officials reported last week that at least 2 patients at the facility have been diagnosed with NTM infections.

Bacterial Infections Prompt 2 Heater-Cooler Lawsuits in Pennsylvania

June 29, 2016 – A pair of lawsuits have been filed against York Hospital and LivaNova, manufacturer of a heater-cooler device linked to an outbreak of bacterial infections throughout Pennsylvania. The complaints were filed last week in the York County Court of Common Pleas, coming about 8 months after York Hospital notified approximate 1,300 open heart surgery patients that they could have been exposed to NTM infections.

FDA Warns of Heart Infection with LivaNova Stӧckert 3T Heater-Cooler

June 1, 2016 – The FDA issued a warning today about an increased risk of mycobacterium chimaera infections associated with use of the LivaNova Stӧckert 3T heater-cooler device. A European study linked cases of the infection to samples taken from Stӧckert 3T heater-coolers used during open heart surgery.

“The results of this paper suggest a direct link between the M. chimaera to which the European patients were exposed and became infected during open-chest cardiac surgery, and 1 specific heater-cooler model – the 3T,” the agency said. “FDA believes these [nontuberculous mycobacterium] infections associated with the 3T are rare. However, they are difficult to detect because patients infected with M. chimaera may not develop symptoms and signs of infection for months to years after initial exposure.”

Doctors Fear ‘Hidden Epidemic of Fatal Infections’ from Heater-Cooler Devices

February 10, 2016 – A “slow-brewing epidemic” of life-threatening Mycobacterium chimaera infection among cardiac surgery patients treated with heater-cooler devices is causing serious worries in the medical community, according to the blog Controversies in Hospital Infection Prevention. The three physicians who write the blog (all of whom work for the University of Iowa Hospitals and Clinics) are so concerned that they are publicizing one of their own patients who was recently developed a Mycobacterium chimaera infection in order to alert the public. The patient, who had had cardiac surgery in 2012 and later returned with an unexplained fever, was diagnosed with the illness “that no doubt came from the {Heater-Cooler} device used during surgery” after prolonged examinations that included a bone-marrow biopsy, according to National Geographic.

UIHC Warns Patients of Heater-Cooler Infections

February 5, 2016 – The University of Iowa Hospitals and Clinics (UIHC) has sent letters to about 1,500 patients after at least one person who underwent surgery with a heater-cooler device developed a severe infection, according to The Gazette. The patient was diagnosed on Jan. 19, and the link to the heater-cooler device was made the next day. By Jan. 23, the facility’s old equipment had been replaced.

“We regret that any patient within our care could be affected by this situation and apologize for any concern it causes,” UHIC said in a news release. “We are absolutely committed to making sure our patients have the information and care they need.”

Big Problems with Heater Cooler Manufacturer, FDA Says

January 6, 2016 – A warning letter sent by the FDA to the maker of a heater-cooler device linked to infections and deaths at a Pennsylvania hospital highlights major problems with the manufacturer’s cleaning protocol. The company, Italy-based Sorin Group, failed to provide adequate information regarding how its new cleaning procedures prevent biofilm from growing in the heater-coolers, according to the FDA.

Pennsylvania Man Files Notice of Claim Against York Hospital Over ‘Very Poorly Cleaned’ Heater-Cooler

November 20, 2015 – A man from Red Lion, PA, who underwent open-heart surgery at WellSpan York Hospital filed a notice of claim today against the facility. According to the notice, John Elmer Bosley was exposed to nontuberculous mycobacteria “via a very poorly cleaned heater/cooler machine used during the surgery.” Click here to learn more.

Hotline Opened to Report Heart Surgery Infections

November 18, 2015 – A York Hospital hotline for doctors whose open-heart surgery patients developed infections has received more than 60 calls, according to PennLive. The hotline was established to provide information for doctors caring for patients who might have been exposed to infections after being treated with heater-cooler devices during surgery.

CDC Recommendations

The CDC has issued recommendations (PDF) to health officials, healthcare providers and facilities to be on the lookout for NTM infections among patients who have undergone cardiac surgery, and to take all necessary precautions in order to prevent such illnesses. The agency is working with local and state health officials, as well as with the FDA.

“The most important action to protect patients will be to remove contaminated heater-coolers from operating rooms, and ensure that those in service are correctly maintained,” CDC said.

CDC also advises patients who have recently undergone cardiac procedures to consult their physician if they were treated with a heater-cooler device, or if they are experiencing symptoms such as fever, pain, redness, heat or pus around their incision, night sweats, joint/muscle pain or fatigue.

Hip & Knee Surgery Infections

This is not the first time heating and cooling systems have been linked to severe injuries. Manufacturers of the Bair Hugger forced-air warming blanket are facing numerous lawsuits from patients who allege they developed serious infections after they had hip or knee replacement surgery in which the device was used.

Do I Have a Heater-Cooler Lawsuit?

The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in heater-cooler lawsuits. We are handling individual litigation nationwide and currently investigating potential settlements in all 50 states.

Free Confidential Case Evaluation: Again, if you or a loved one was injured or infected by a heater-cooler device, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and we can help.

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