# China NMPA Product Recall - Portable automated peritoneal dialysis machine

Source: https://www.globalkeysolutions.net/records/china_product_recall/baxter-healthcare-corporation/898edd91-bfab-4378-9cb9-c32050565b75/
Source feed: China

> China NMPA product recall for Portable automated peritoneal dialysis machine by Baxter Healthcare Corporation published July 17, 2013. Recall level: . On July 17, 2013, the National Medical Products Administration (NMPA) published information regardin

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## Details

- Record Type: CHINA_PRODUCT_RECALL
- Title: Baxter Healthcare Corporation recalls portable automated peritoneal dialysis machines.
- Company Name: Baxter Healthcare Corporation
- Publication Date: 2013-07-17
- Product Name: Portable automated peritoneal dialysis machine
- Recall Reason: 1. The product is a peritoneal dialysis machine, consisting of a main unit, control panel, heater, and power cord. Software version number 10.2. 2. In markets outside of China, there have been cases of IIPV (increased intraperitoneal fluid). Although these events were caused by patient error and/or incorrect formulation, to reduce the risk of JJPV, Baxter has decided to upgrade the software of its HomeChoice series machines globally to version 10.4.
- Discovering Company: Baxter Medical Supplies Trading (Shanghai) Co., Ltd.
- Manufacturing Company: Baxter Healthcare Corporation
- Summary: On July 17, 2013, the National Medical Products Administration (NMPA) published information regarding a voluntary recall initiated by Baxter Healthcare Corporation, through its Chinese subsidiary, Baxter Medical Supplies Trading (Shanghai) Co., Ltd. The recall, reported on May 23, 2013, involves its portable automated peritoneal dialysis machines, specifically the Homechoice Model 5C4474, impacting 439 units in China. The primary issue identified was an increase in intraperitoneal fluid (IIPV) experienced by patients during the use of the device. Although initial findings suggested patient misuse or incorrect formulation contributed to these incidents in markets outside China, Baxter opted for a proactive global software upgrade to mitigate potential risks. Operating under the NMPA's regulatory framework for medical devices, Baxter's required actions include a comprehensive software upgrade of all affected HomeChoice machines to version 10.4, performed by their engineers. Additionally, Baxter committed to drafting and issuing a "Customer Communication Letter" to inform users about this upgrade. The NMPA requested all regional food and drug administrations to enhance supervision of similar products. This recall underscores a commitment to patient safety through device modification and transparent communication.

Company: https://www.globalkeysolutions.net/companies/baxter-healthcare-corporation/8501ed99-7e58-4715-bb3b-510947efca69/