Mycobacteria Chimaera Infections Associated With Heater-Cooler Unit Use During Cardiopulmonary Bypass Surgery

In December 2016, a hospital in Los Angeles County, California reported two Mycobacterium avium complex infections, later identified as Mycobacterium chimaera, in patients with a recent history (<5 years) of cardiopulmonary bypass surgery. Both surgical procedures used the Sorin Stöckert 3T (Sorin Group, Munich, Germany) heater-cooler unit brand (currently LivaNova PLC, London, United Kingdom) to heat and cool blood. These heater-cooler units have been linked to outbreaks of M. chimaera infections among patients with similar surgical histories in Europe and the United States. Sorin Stöckert 3T heater-cooler units contaminated during manufacturing before September 2014 were identified as the source of infection through emission of bioaerosols containing M. chimaera during surgery, and these units have been removed and replaced by the hospital. M. chimaera is a nontuberculous mycobacterium first described in 2004. M. chimaera infection diagnosis is challenging because clinical manifestations can take months or years to develop and are often nonspecific - infections have been diagnosed up to 6 years after initial surgical exposure. In hospitals with confirmed M. chimaera infections, reported incidence rates among heater-cooler unit–exposed patients ranged from one per 100 persons to one per 1,000 persons, and the case-fatality rate was approximately 50%. Infections were reported most frequently among patients who had valve replacement or other implants during surgery. The CDC released a health alert in October 2016 recommending that hospitals that used Sorin Stöckert 3T heater-cooler units notify patients who were potentially exposed during 2012–2016. Because the Los Angeles hospital used implicated heater-cooler units, an investigation was initiated by the Los Angeles County Department of Public Health in December 2016, to enhance case findings and implement control measures. During the investigation, approximately 4,000 patients were sent letters per CDC guidance, describing the potential exposure and instructing them to seek care if they experienced signs or symptoms consistent with M. chimaera infection, such as fatigue, unexplained fever, night sweats, weight loss, or wound infection. By May 2017, 20 confirmed cases of M. chimaera infection had been identified in patients with a history of cardiopulmonary bypass during 2013–2016. Fifteen (75%) cases were identified by clinicians during patient hospitalization, follow-up care, or subsequent surgical procedures at the Los Angeles hospital or affiliated facilities. Five (25%) patients sought care because they received a patient notification letter and subsequently received a diagnosis of M. chimaera infection. All five patients identified through patient notification letters had valve replacements or implants inserted during surgery, and all five remain alive. Thirteen of the 15 patients identified during hospitalization, follow-up care, or subsequent surgery had valve replacements or implants, and eight of these 15 patients were alive. Informing and reminding exposed persons to seek care for M. chimaera–associated nonspecific symptoms can be important for diagnosis, particularly because subsequent care might not occur at the exposure hospital, limiting the likelihood of complete exposures being known. Because of M. chimaera’s long incubation time, hospitals that used implicated heater-cooler units could consider additional proactive steps toward early detection of infection, such as annual patient renotification and implementation of clinician alerts in electronic medical records. Source

If you or a loved one were seriously injured (or worse) due to a heater-cooler device in the United States, you should promptly find a defective medical device claim lawyer who may investigate your heater-cooler device claim for you and represent you in a claim for compensation due to the harm you or your loved one suffered as a result of a defective heater-cooler device.

Visit our website or call us toll-free in the United States at 800-295-3959, to find heater-cooler device claim lawyers in your state who may assist you.

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This entry was posted on Tuesday, January 22nd, 2019 at 5:18 am. Both comments and pings are currently closed.

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