# China NMPA Product Recall - SynchroMed II Programmable Drug Infusion System

Source: https://www.globalkeysolutions.net/records/china_product_recall/medtronic-inc/f9a6bfa9-379a-48b4-bb4f-2e258acf107b/
Source feed: China

> China NMPA product recall for SynchroMed II Programmable Drug Infusion System by Medtronic Inc. published September 02, 2013. Recall level: . Medtronic Inc. initiated multiple voluntary global recalls of its SynchroMed II Drug Infusion System

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Medtronic Inc. is recalling its drug infusion systems.
- Company Name: Medtronic Inc.
- Publication Date: 2013-09-02
- Product Name: SynchroMed II Programmable Drug Infusion System
- Recall Reason: Pocket filling can lead to accidental injection of medication into the patient's subcutaneous tissue; there is a potential risk of misalignment and blockage at the interface between the catheter and the pump; drug mixing during single-dose filling of the catheter can lead to abnormal dosing, potentially resulting in overdose or underdose.
- Discovering Company: Medtronic (Shanghai) Management Co., Ltd.
- Manufacturing Company: Medtronic Inc.
- Summary: Medtronic Inc. initiated multiple voluntary global recalls of its SynchroMed II Drug Infusion Systems, as reported to the National Medical Products Administration (NMPA) with a publication date of September 2, 2013, and recall reports dating from July 3, 2012, and July 3, 2013. The NMPA, referencing registration certificate SFDA (1) 20103543342, requested strengthened supervision of these products.

The primary issues leading to these recalls included: 1. "Pocket fill" events, where medication was accidentally injected into subcutaneous tissue or the pump pocket instead of the intended drug pump during reperfusion. 2. Catheter-pump connection interface risks, specifically involving the seamless connection (SC) intrathecal catheter connectors, which had a potential for incomplete connection, misalignment, and blockage. 3. Abnormal drug administration during single-dose catheter filling, where the design allowed medication and non-medication fluids to mix, leading to rapid, abnormal drug delivery or dilution in the cerebrospinal fluid. This could result in overdose, underdose, reduced efficacy, and severe adverse events including confusion, respiratory depression, coma, or death.

Medtronic's required actions involved providing "Key Steps in Drug Pump Reperfusion Procedure" and customer notification letters to physicians, ensuring understanding and confirmation. For the catheter connector issue, previously designed products were recalled, and a redesign was implemented. For the single-dose filling problem, doctors were notified and asked to sign receipts confirming their understanding of the risks and corrective actions. Medtronic sales representatives were tasked with direct communication and documentation of these recall activities.

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