澳大利亚患者Fay Sherret在2015年进行心脏瓣膜置换手术后，因3T Heater-Cooler医疗设备的设计缺陷感染了致命细菌Mycobacterium chimaera，于2017年7月去世1。该设备制造商Sorin Group早在2014年8月就检测到工厂水供应和生产线中存在这种细菌1，但这一已知风险未能阻止设备的继续使用。
该医疗设备存在严重的设计漏洞，允许水箱被细菌污染并通过雾化方式喷入患者体内1。澳大利亚已有包括Fay Sherret在内的4名患者因该设备相关感染死亡，其中3人在2016年至2022年间过世1。全球范围内，超过120例与加热冷却器相关的感染已被确认1。如果细菌在心脏中建立感染，患者死亡率高达50%1。
在澳大利亚，2021年至去年期间，澳大利亚治疗用品管理局收到22份3T设备污染报告，其中4例患者被感染、1例患者死亡1。澳大利亚25%的3T设备检测呈阳性1。荷兰Radboud大学医学中心分子菌学参考实验室主任Jakko Van Ingen将该病称为"极其难以治愈"1。意大利医生在《医院感染杂志》2020年发表的文章指出制造商的消毒程序"无效和/或不充分"1。
尽管风险证据充分，监管部门批准的设计修复似乎未能有效解决问题，该设备仍在医院中使用1。LivaNova在2019年就该设备在美国的诉讼中达成2.25亿美元和解1，但澳大利亚患者仍在接触这一潜在致命的医疗设备。
Australian patient Fay Sherret died from a bacterial infection contracted during heart valve replacement surgery, caused by a design flaw in the 3T Heater-Cooler device manufactured by LivaNova.1 Sherret underwent the procedure in 2015 and died in July 2017, approximately 18 months after her operation, from complications related to infection with Mycobacterium chimaera.1
The 3T device contains a known design vulnerability that allows water tanks to become contaminated with bacteria, which then enters patients' bodies through aerosolized spray during cardiac surgery.1 Manufacturer Sorin Group detected Mycobacterium chimaera in its factory water supply and production lines as early as August 2014.1 In Australia, at least four patients have died from infections linked to the equipment, while more than 120 cases of infection associated with heater-cooler devices have been confirmed globally.1 According to Australia's Therapeutic Goods Administration (TGA), the mortality rate for patients in whom the bacteria establishes itself in the heart reaches 50 percent.1 Between 2021 and the previous year, the TGA received 22 reports of contamination in 3T devices, resulting in four infected patients and one death; testing revealed that 25 percent of 3T devices detected tested positive for the bacteria.1
Despite regulatory approval of design modifications, the corrected versions appear insufficient to resolve the underlying problem, and the equipment remains in hospital use.1 LivaNova settled litigation in the United States regarding the device for $225 million in 2019.1 Jakko Van Ingen, director of the molecular mycology reference laboratory at Radboud University Medical Center in the Netherlands, characterized the infection as "extremely difficult to treat."1 Italian physicians published an article in the Journal of Hospital Infection in 2020 asserting that the manufacturer's sterilization procedures were "ineffective and/or insufficient."1
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