# China NMPA Product Recall - Centrifugal pump blood control and detection system

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-shanghai-management-co-ltd/a79b7582-b88a-46e6-bef7-9c111f55a1a6/
Source feed: China

> China NMPA product recall for Centrifugal pump blood control and detection system by Medtronic (Shanghai) Management Co., Ltd. published March 29, 2021. Recall level: Level 1. Medtronic (Shanghai) Management Co., Ltd. initiated a Class I voluntary recall, published on March 2

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic (Shanghai) Management Co., Ltd. is voluntarily recalling its centrifugal pump blood control and detection system.
- Company Name: Medtronic (Shanghai) Management Co., Ltd.
- Publication Date: 2021-03-29
- Product Name: Centrifugal pump blood control and detection system
- Recall Level: Level 1
- Recall Reason: Due to a supplier's component discontinuation, the original DC-DC converter assembly (PN A09674003) used on this equipment was replaced with a spare DC-DC converter assembly (PN M975344A001) that meets design specifications. The difference in the maximum voltage input of the spare assembly compared to the original assembly resulted in insufficient voltage specifications for the host system controller module (part number (PN) 90909004). Investigation revealed that this issue may cause the instrument to shut down (pump not rotating), the user interface to malfunction (blank screen), and to emit smoke and a burning odor before and during use.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic (Shanghai) Management Co., Ltd.
- Summary: Medtronic (Shanghai) Management Co., Ltd. initiated a Class I voluntary recall, published on March 29, 2021, for its centrifugal pump blood control detection system. This action was prompted by a critical issue stemming from a supplier's discontinuation of a key component. The original DC-DC converter assembly (PN A09674003) was replaced with a different spare part (PN M975344A001). Investigations revealed that this replacement component had a different maximum voltage input, leading to inadequate voltage specifications for the device's main system controller module (PN 90909004).
The identified malfunction poses several significant risks during device operation. These include the potential for the instrument to shut down, causing the pump to stop rotating, and user interface malfunctions such as a blank screen. Furthermore, there is a risk of smoke and a burning odor emanating from the device both before and during use. This recall is being conducted under the oversight of China's National Medical Products Administration.
Medtronic has advised users to consult the centrifugal pump blood control monitoring system operation and reference manual for detailed procedures. Crucially, the company has confirmed that, as of the recall date, no patient injuries or adverse events related to this specific issue have been reported globally. The recall targets specific models, specifications, and batches, with further details available in the "Medical Device Recall Event Report Form."

Company: https://www.globalkeysolutions.net/companies/medtronic-shanghai-management-co-ltd/e5ba243d-a47a-4442-84d4-1e11f92f75e2/