# China NMPA Product Recall - artificial heart-lung machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/terumo-cardiovascular-systems-corporation/17ce8c55-ba3a-495d-90aa-9db470c1f34b/
Source feed: China

> China NMPA product recall for artificial heart-lung machine by Terumo Cardiovascular Systems Corporation published October 29, 2019. Recall level: Level 2. Terumo Cardiovascular Systems Corporation (TCVS), through its agent Terumo (China) Investment Co., L

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Terumo Cardiovascular Systems Corporation initiates voluntary recall of cardiopulmonary bypass machines
- Company Name: Terumo Cardiovascular Systems Corporation
- Publication Date: 2019-10-29
- Product Name: artificial heart-lung machine
- Recall Level: Level 2
- Recall Reason: Terumo Cardiovascular Systems Corporation (TCVS) recently discovered a potential discrepancy between the gas flow rate output from the Electronic Gas Mixing and Monitoring (EPGS) unit used in cardiopulmonary bypass machines and the value displayed on the central monitoring display (CCM) of the machine. Following investigation and analysis, a defect was found in the internal flow meter of the EPGS unit, leading to inaccurate readings. No notifications regarding other module malfunctions have been received. TCVS has confirmed the complaint about the malfunctioning internal flow meter of the EPGS unit, but to date, there have been no reports of patient injury or harm caused by this issue. Terumo (China) has also not received any market feedback, complaints, adverse events, or injury reports related to this issue.
- Discovering Company: Terumo (China) Investment Co., Ltd.
- Manufacturing Company: Terumo Cardiovascular Systems Corporation
- Summary: Terumo Cardiovascular Systems Corporation (TCVS), through its agent Terumo (China) Investment Co., Ltd., initiated a voluntary Class II recall of its System 1 Artificial Heart-Lung Machines. Reported to the National Medical Products Administration (NMPA) on October 15, 2019, and published on October 29, 2019, this action addresses a critical defect in the Electronic Gas Mixing Monitoring (EPGS) unit. It was discovered that the EPGS unit's internal flow meter provided inaccurate gas flow rate readings, potentially inconsistent with values displayed on the central monitoring display (CCM). While no patient injuries or adverse events have been reported, the potential for inaccurate monitoring during extracorporeal circulation for cardiac surgery necessitated this recall. The affected product, identified by registration number CFDA (Imported) No. 20083451664, is part of a global recall, with one unit in China requiring intervention as another was previously scrapped. Terumo (China) is implementing several corrective actions, including sending recall notices to customers and arranging engineer visits. Engineers will guide customers on using external mechanical flow meters for cross-verification, advising discontinuation of machine use if inconsistencies are found. Subsequently, the company will replace defective EPGS internal flow meters provided by TCVS and closely monitor the product's future use to ensure patient safety.

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