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

Source: https://www.globalkeysolutions.net/records/china_product_recall/maquet-cardiopulmonary-ag/38fe1c3e-3ffa-4e8a-9403-cb8723498b34/
Source feed: China

> China NMPA product recall for Artificial Heart-Lung Machine - Heat Exchange Water Tank by MAQUET Cardiopulmonary AG published January 13, 2017. Recall level: . Maquet (Shanghai) Medical Equipment Co., Ltd., the China-based responsible unit for MAQUET Cardiopul

---

## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Maikewei (Shanghai) Medical Equipment Co., Ltd. is voluntarily recalling the heat exchange water tank for its artificial heart-lung machine.
- Company Name: MAQUET Cardiopulmonary AG
- Publication Date: 2017-01-13
- Product Name: Artificial Heart-Lung Machine - Heat Exchange Water Tank
- Recall Reason: Maquet has revised its cleaning and disinfection procedures for the HCU40 cardiopulmonary bypass machine's heat exchange tank. The procedures now include standard disinfection methods and advanced disinfection methods to eliminate atypical mycobacteria in the tank. Existing HCU40 cardiopulmonary bypass machines with heat exchange tanks (serial numbers less than 90441000) require an upgrade before implementing the new disinfection procedures.
- Discovering Company: Maikewei (Shanghai) Medical Equipment Co., Ltd.
- Manufacturing Company: MAQUET Cardiopulmonary AG
- Summary: Maquet (Shanghai) Medical Equipment Co., Ltd., the China-based responsible unit for MAQUET Cardiopulmonary AG, initiated a voluntary recall for specific HCU40 Heart-Lung Machine - Heat Exchange Water Tank units. This action, reported by the National Medical Products Administration (NMPA) on January 13, 2017, stemmed from the company's revision of cleaning and disinfection procedures for the medical device. The core issue identified was the potential for atypical mycobacteria contamination within the tank if previous disinfection protocols were followed, posing a patient safety risk. The recall was formally reported by the company on December 27, 2016. To rectify this concern, Maquet developed new standard and advanced disinfection methods. The recall specifically targets HCU40 units with serial numbers below 90441000, affecting 44 units imported to China out of a global total of 51. The required actions include issuing a comprehensive "Recall Notice" to all affected users. Furthermore, authorized Maquet service personnel are dispatched to hospitals to upgrade the heat exchange water tanks on site. Crucially, a revised instruction manual is being provided, and users are receiving thorough training on the updated cleaning and disinfection procedures to ensure proper device maintenance and enhance patient safety in cardiac surgery settings. This proactive measure underscores the company's commitment to mitigating potential health risks.

Company: https://www.globalkeysolutions.net/companies/maquet-cardiopulmonary-ag/63ce4d48-8350-4a6e-bbe2-5003aa14ae22/