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]