# China NMPA Product Recall - Artificial Heart-Lung Machine - Heat Exchange Water Tank

Source: https://www.globalkeysolutions.net/records/china_product_recall/terumo-cardiovascular-systems-corporation/0376dc1c-4162-487b-afdc-56227bee2321/
Source feed: China

> China NMPA product recall for Artificial Heart-Lung Machine - Heat Exchange Water Tank by Terumo Cardiovascular Systems Corporation published January 24, 2019. Recall level: Level 2 Recall. Terumo Cardiovascular Systems Corporation initiated a Class II voluntary recall of its artificial he

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Terumo Cardiovascular Systems Corporation is voluntarily recalling the heat exchange tank for its cardiopulmonary bypass machines.
- Company Name: Terumo Cardiovascular Systems Corporation
- Publication Date: 2019-01-24
- Product Name: Artificial Heart-Lung Machine - Heat Exchange Water Tank
- Recall Level: Level 2 Recall
- Recall Reason: In response to the ongoing FDA investigation into nontuberculous mycobacterial (NTM) infections in heat exchange systems, Terumo has revised and updated its cleaning guidelines for three heat exchange systems: Sarns® TCM, TCM II, and HX2®, to reduce the risk of patient infection. Nontuberculous mycobacteria can potentially proliferate in the water tanks of heat exchange systems. Although the water in the heat exchange system does not directly contact the patient's blood or bodily fluids, contaminated water droplets in the tank can escape (atomize and disperse) from the heat exchange system into the operating room, spreading bacteria into the air. This can cause infections during open-chest surgery, in patients with cardiovascular disease, or other adverse events.
- Discovering Company: Terumo (China) Investment Co., Ltd.
- Manufacturing Company: Terumo Cardiovascular Systems Corporation
- Summary: Terumo Cardiovascular Systems Corporation initiated a Class II voluntary recall of its artificial heart-lung machine heat exchange tanks, including models TCM II and HX2, impacting 104 units sold in China. This action, published by the National Medical Products Administration (NMPA) on January 24, 2019, stems from an ongoing US FDA investigation into nontuberculous mycobacterial (NTM) infections associated with heat exchanger equipment. The core issue is the potential for NTM to proliferate within the heat exchanger water tanks. Although the water does not directly contact patient blood, contaminated water droplets can atomize and disperse into the operating room air, posing a risk of infection or other adverse events during open-chest surgery, particularly for cardiovascular patients. In response, Terumo (China) Investment Co., Ltd. has revised and updated its cleaning guidelines for the affected Sarns® heat exchange equipment. The company's required actions include distributing these new guidelines to 63 hospitals across China, encompassing 72 units still in use. Furthermore, Terumo committed to monitoring the hospitals' implementation of these updated cleaning protocols and providing hands-on guidance from after-sales service personnel as needed to ensure proper adherence and minimize patient risk.

Company: https://www.globalkeysolutions.net/companies/terumo-cardiovascular-systems-corporation/b70f7de8-3764-4401-8652-487feae69483/