Patients suffering mycobacterial infections following open-heart surgery with a Sorin 3T Heater-Cooler or a Terumo HX2 should call the Philadelphia, PA attorneys of McEldrew Young at 1-800-590-4116 for a free, initial legal consultation.
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Local Philadelphia Infection Outbreaks and Heater-Cooler Lawsuits
Previous Pennsylvania Outbreaks
Over the past two years Wellspan York Hospital and Hershey Medical Center have publicly warned that several patient deaths due to mycobacterial infection was the result of a contaminated Sorin 3T heater-cooler. These devices are used within large open cavity surgical procedures, such as open heart surgeries and lung transplants. The infections are caused by recycled and contaminated water, used to cool the system, being allowed to make contact with the surgical site after being emitted through the devices exhaust system. The circulated water was not intended to ever make contact with the surgical site.
New Philadelphia Outbreak
There has been another similar outbreak at an unknown Philadelphia hospital. The outbreak is known to have occurred as early as 2012, is potentially ongoing and has not been publically disclosed. It is believed that the Philadelphia infections involve(d) the use of a Terumo Hx2 Heater-cooler device. This infection again involves a contaminated or defective heater / cooler device that is causing M. absceccus, M. chimaera and/or M. avium intracellulare mycobacterial infections bloodstream infections – also known generally as sepsis. Estimates indicate that potentially hundreds of patients may have been exposed to deadly mycobacteria, without their knowing or being informed of the risk by the hospital or the various health departments.
The Philadelphia Inquirer has identified Penn Presbyterian Medical Center as the location of the infections in Philly.
Nontuberculous Mycobacteria Infections
In all of these instances of infection, the patient suffered a blood infection or sepsis caused by different types of mycobacteria. Mycobacteria are aerobic and non-motile bacteria that grow similar to a fungus. Mycobacterial are able to establish and grow in the blood streams, however each type of mycobacteria grows at different speeds.
M. absceccus is a rapidly growing mycobacteria that has recently demonstrated an intrinsic and acquired resistance to certain antibiotics. M. absceccus can be responsible for a wide spectrum of soft tissue and blood infections in immunosuppressed patients. M. absceccus is considered a major public health concern due to its antibiotic resistance.
Possible signs of NTM infection in patients who have undergone cardiopulmonary procedures include: fatigue, breathing difficulty, persistent cough or cough with blood, pain, fever, redness/heat/pus at the surgical site, joint paint, muscle pain, joint pain, night sweats, weight loss, abdominal pain, nausea and vomiting.
Other types of mycobacterial that have been identified within patients are M. chimaera and M. avium intracellulare. M. chimaera is a slow-growing organism predominantly found in water supplies.
M. avium and M. intracellulare are present in soil and water. They usually enter via the gastrointestinal tract but can also enter via the lungs as it is easily aerosolized and inhaled. Generally referred to as MAC, they can lead to fever, diarrhea and malabsorption, as well as disseminate the bone marrow. The symptoms are similar to tuberculosis.
Update: Legionnaires’ Disease
Physicians at the University of Washington Medical Center reported the discovery of heater-cooler units contaminated with the bacteria that cause Legionnaires’ Disease. Legionnaires’ Disease is a severe form of pneumonia where the infection causes lung inflammation. About one out of ten people who contract Legionnaires’ Disease will die from it.
About the Heater-Cooler Manufacturers
LivaNova / Sorin and the 3T
Sorin was an Italian company founded in 1956 to tackle problems in the production of nuclear energy. It was an acronym for Societa Richerche Impianti Nucleari. In the 1980s and 1990s, it transformed from a nuclear company into a medical company due to its tremendous scientific experience and the nationalization of the electric utilities in Italy. When Sorin Group merged with Cyberonics in 2015, it formed a new UK-based company, LivaNova.
Sorin makes the 3T Heater-Cooler. The device provides temperature-controlled water to oxygenator heat exchangers, cardioplegia heat exchangers, and/or patient warming/cooling blankets for cardiopulmonary bypass procedures. The device eliminates the need for ice and water supply in the operating room.
Terumo and the Terumo HX2
Terumo Corporation is a Japanese company founded in 1921. It sells a variety of medical devices involving cardiac & vascular products (stents, oxygenators, catheters), blood management and general hospital products (digital thermometers, blood pressure and glucose monitoring systems, IV catheters). Terumo makes the HX2 Heater-Cooler.
The Terumo HX2 is a temperature management system that supplies temperature-controlled water to arterial and cardioplegia heat exchangers.
Injured? Call 1-800-590-4116
The FDA on Heater-Cooler Systems
In an October 2015 communication, the FDA provided information to health care providers concerning steps to mitigate the risk of infections to patients following cardiothoracic surgeries involving all heater-cooler devices. The letter detailed 32 medical device reports of patient infections associated with the devices. The FDA warned that the Nontuberculous Mycobacteria (NTM) infections can impact very ill patients and/or individuals with compromised immune systems. In order to combat the problem, it recommended health care facilities and staff take a number of steps to decrease the risk of an infection.
On December 29, 2015, the FDA issued a warning letter for Sorin’s Stockert 3T Heater-Cooler System after inspections in Munchen, Germany and Arvada, Colorado revealed significant quality issues. Later, On June 1, 2016, the FDA issued a safety communication to health care providers, patients and hospital staff concerning mycobacterium chimaera infections associated with Sorin’s 3T Heater-Cooler System. The communication added information about a possible link between M. chimaera and the 3T heater-cooler system. Specifically, the FDA warned about the possibility that units shipped from the factory prior to September 2014 were contaminated as manufacturer testing found a contaminated production line and water supply at their manufacturing facility. It also noted a higher risk of patient infection in surgeries involving a heart valve, graft, LVAD, or heart transplant.
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or Surgical Team Following an Infection?
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Our trial attorneys are ready to litigate on your behalf. They have handled thousands of oral arguments, mediations, arbitrations and jury trials. James J. McEldrew, III is a Past President of the Philadelphia Trial Lawyers Association. He has an extensive set of contacts with local and national physicians in order to have your medical file expertly reviewed to determine whether there has been a case of wrongdoing by your medical team or the products involved in your surgery.
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