# China NMPA Product Recall - Drug infusion system

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/7d846907-7c60-430c-b6b0-bab86374a787/
Source feed: China

> China NMPA product recall for Drug infusion system by Medtronic Inc. published April 08, 2014. Recall level: . The National Medical Products Administration (NMPA) and the Shanghai Municipal Food and Drug Adminis

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. of the United States is recalling its drug infusion systems.
- Company Name: Medtronic Inc.
- Publication Date: 2014-04-08
- Product Name: Drug infusion system
- Recall Reason: Medtronic has discovered that the SynchroMed II drug infusion system may experience overdosing. Overdosing is defined as an infusion rate exceeding the programmed infusion rate specified on the label by more than 14.5%. When overdosing occurs, it results in a difference in drug dosage during reperfusion, with less drug being withdrawn than expected. The cause of the pump malfunction leading to overdosing is under investigation and has not yet been determined to be related to any specific pump batch, drug used, or geographic region. According to reports, overdosing has occurred as early as 5 months post-implantation and throughout the pump's lifespan. Reports received indicate that once the infusion pump begins overdosing, the infusion rate may continue to increase, sometimes suddenly.
- Discovering Company: Shanghai Municipal Food and Drug Administration
- Manufacturing Company: Medtronic Inc.
- Summary: The National Medical Products Administration (NMPA) and the Shanghai Municipal Food and Drug Administration reported a voluntary recall by Medtronic Inc. of its SynchroMed II drug infusion systems. Publicized on April 8, 2014, this recall addresses a significant safety concern where the device may deliver medication at a rate exceeding the programmed setting by more than 14.5%, potentially leading to patient overdose. This issue results in incorrect drug dosages, with less medication drawn back than expected, affecting patients requiring long-term infusions. The cause of this pump malfunction is currently under investigation, and it has not yet been attributed to specific product batches, drugs, or geographic regions, with reported incidents occurring from five months post-implantation and continuing throughout the pump's lifespan. Medtronic Inc. is the manufacturer, with Medtronic Shanghai (Management) Co., Ltd. responsible for distribution in China. In response, regulatory bodies have requested all provincial, autonomous region, and municipal food and drug administrations to strengthen their supervision and management of similar medical products to ensure patient safety.

Company: https://www.globalkeysolutions.net/companies/medtronic-inc/398d5f72-c7d2-4c97-94fc-fbef4cf2336d/