Update: 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.”
What’s the Problem?
Heater-cooler devices are used to warm or cool a patient’s blood during cardiothoracic surgery and other medical procedures. The devices consist of tanks that provide temperature-controlled water to external heat exchangers or warming/cooling blankets through closed circuits. Learn more about the problems with heater-cooler devices on our heater-cooler FAQ page.
Although the water in the circuits does not come into direct contact with the patient, the Centers for Disease Control and Prevention (CDC) reports that contaminated water can enter other parts of the heater-cooler or transmit non-tuberculosis mycobacteria (NTM) through the air via the system’s exhaust vent and onto the patient.
Heater-Cooler Devices Linked to Infection Problems: FDA Warning
In October 2015, the FDA issued a safety communication regarding problems associated with medical heater-cooler systems. According to the warning, at least 32 adverse event reports were linked to the devices between January 2010 and August 2015. Only 8 of the reports came from inside the U.S, associated with 3 events describing patient infections. The rest mainly came from Western Europe.
“It is possible that some cases have not been reported to the FDA,” the agency said. “It is challenging for a health care facility, health care provider, manufacturer, or patient to recognize that infections, particularly NTM infections, may be associated with the use or exposure to a particular medical device.”
Pennsylvania Hospital Warns 1,300 Patients of Heater-Cooler Infection Risk
WellSpan York Hospital, in York, PA, has warned about 1,300 patients who underwent open-heart surgery there within the past 4 years that they may be at risk of developing a life-threatening NTM infection. The infections may have contributed to the deaths of 4 patients, according to CBS News.
Hospital staff were alerted to the problem when a recent study published in the journal Clinical Infectious Diseases revealed a previously unknown risk of infection — aerosolized NTM bacteria escaping from heater-coolers used during open-heart surgery — which may have contributed to the deaths of 6 heart surgery patients in Europe.
“Based on our joint investigation, the CDC determined that the NTM infections identified in our patients are likely linked to the heater-cooler devices, paralleling the findings of the European study,” said Dr. R. Hal Baker, WellSpan Health’s senior vice president for clinical improvement.
Hershey Med Reports Same Infections as York Hospital
On November 10, Penn State Milton S. Hershey Medical Center announced that it was warning about 2,300 patients who underwent open-heart surgery over the past 4 years that they may be at risk for NTM infection. Two patients who had complex medical conditions have died, according to ABC News.
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.
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.
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.
LivaNova Heater-Cooler Devices Linked to Bacterial Infections in Heart Surgery Patients
October 14, 2016 – The Centers for Disease Control and Prevention (CDC) has linked a rare but potentially lethal bacterial infection that has affected patients in at least 3 U.S. states to contamination from a heater-cooler device used during open-heart surgery. In a report published Thursday by the CDC, researchers said a genomic analysis “strongly” suggests that the infections arose from a common source: Stöckert 3T heater-cooler devices made by LivaNova PLC.
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.
Iowa Hospital Warns Heart Surgery Patients of Infection Risk with Heater-Cooler Devices
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 NTM infections, according to the Des Moines Register. Hospital officials reported last week that two patients at the facility have been diagnosed with the infection.
Bacterial Infection Prompts Heater-Cooler Lawsuit in Pennsylvania
June 30, 2016 – A lawsuit was filed last week in Pennsylvania’s York County Court of Common Pleas on behalf of Vincent Karst, who developed a bacterial infection after undergoing open heart surgery with a heater-cooler device at York Hospital on March 9, 2015. Karst and his wife Rebecca are suing to recover compensation for his injuries. The complaint states that as a “direct and proximate result” of defendants’ behavior, Vincent has experienced severe medical complications including chronic illness, pain and suffering, and a loss of earnings.
Lawsuit Filed Over Heater-Cooler Infection Death
June 27, 2016 – The founder of a York, PA., business died of an NTM infection in November 2015 after undergoing open heart surgery with a heater-cooler device in late 2014, according to a recently-filed lawsuit. The complaint was entered against WellSpan Health, York Hospital and the Sorin Group on behalf of the deceased, David R. Inners. Inners, owner of DRI Machine Shop in Hanover and an avid bicyclist, was 62-years-old.
University of Iowa Warns Patients of Heater-Cooler Infection Risk
February 8, 2016 – The University of Iowa Hospitals and Clinics (UIHC) has sent warning letters to about 1,500 patients after at least one person who underwent surgery with a heater-cooler device was diagnosed with a severe infection, according to The Gazette. Due to privacy concerns, UIHC has released few details on the patient; however, it is known that the diagnosis was made on January 19, and the link to the heater-cooler was made the next day. The university began sending letters out to patients who may have been exposed to infections on February 1.
Claim Filed Against York Hospital Over ‘Very Poorly Cleaned’ Heater-Cooler
A Pennsylvania man who underwent open-heart surgery at WellSpan York Hospital filed a notice of claim against the facility today, according to the York Dispatch. According to the notice, John Elmer Bosley was exposed to nontuberculous mycobacteria “via a very poorly cleaned heater/cooler machine used during the surgery.”
Big Problems with Heater Cooler Manufacturer, FDA Says
January 6, 2016 – A warning letter sent by the U.S. Food and Drug Administration (FDA) to the maker of a heater-cooler device linked to infections and deaths at York Hospital in Pennsylvania 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 or causing waterborne infection, according to the FDA. Click here to learn more.
Pennsylvania Hospital Reports 4 Dead from Heater-Cooler Infections
December 18, 2015 – York Hospital announced on Monday that over the past 5 years, at least 8 of its open heart surgery patients had developed infections that were the ‘probable’ result of contamination from heater-cooler devices. The findings were the result of a joint investigation by the CDC and Pennsylvania Department off Health. The investigation determined that the infections were “likely a contributing factor” in 4 patient deaths, the hospital said in a news release.
What are Non-Tuberculosis Mycobacteria?
NTM is a type of slow-growing bacteria commonly found in soil, water, and tap water, according to the CDC. It is not typically harmful to humans; however, in rare cases it can cause infection in patients who have had invasive medical procedures, particularly in individuals who have compromised immune systems.
NTM Infection Symptoms
- Pain, redness, heat, or pus around a surgical incision
- Weight loss
- Night sweats
- Joint pain
- Muscle pain
- Loss of energy
The most important action to protect patients, according to the CDC, is for hospital staff to remove contaminated heater-coolers from operating rooms, and ensure that those in use are properly maintained. Patients who may have been exposed to NTM during a surgical procedure should watch for the above-listed symptoms and contact their doctor immediately should any signs appear. Due to the potentially long delay between exposure to NTM and appearance of symptoms, identifying infections related to heater-cooler use can be extremely challenging.
Do I Have a Heater-Cooler Class Action 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 suffered a serious infection following a procedure in which a heater-cooler device may have been involved, you should contact our law firm immediately. You may be entitled to a settlement by filing a class action suit and our lawyers can help.