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Home Articles Vol 35,2026 No.2 Detail

Post-authorisation safety evaluation of extracorporeal blood circuit based on literature and MAUDE database

Published on Feb. 27, 2026Total Views: 35 times Total Downloads: 10 times Download Mobile

Author: LI Kaili 1 ZENG Baoqi 1, 2, 3 HUANG Ling 4 WANG Qiping 4 SUN Feng 1, 2, 5, 6, 7, 8

Affiliation: 1. Department of Epidemiology and Biostatistics, School of Public Health, Peking University, Beijing 100191, China 2. Key Laboratory of Epidemiology of Major Diseases (Peking University), Ministry of Education, Beijing 100191, China 3. Central Laboratory, Tianjin Fiſth Central Hospital (Binhai Hospital of Peking University), Tianjin 300450, China 4. Center for Pharmacovigilance of Hainan Province, Hainan 570100, China 5. Department of Ophthalmology, Peking University Third Hospital, Beijing 100191, China 6. School of Traditional Chinese Medicine, Xinjiang Medical University, Urumqi 830017, China 7. School of Public Health, Shihezi University, Shihezi 832000, Xinjiang Uygur Autonomous Region, China 8. Hainan Institute of Real World Data, Hainan 571437, China

Keywords: Extracorporeal blood circuit Adverse events Literature search Signal detection Product quality Connection problems Operational technique

DOI: 10.12173/j.issn.1005-0698.202510009

Reference: LI Kaili, ZENG Baoqi, HUANG Ling, WANG Qiping, SUN Feng. Post-authorisation safety evaluation of extracorporeal blood circuit based on literature and MAUDE database[J]. Yaowu Liuxingbingxue Zazhi, 2026, 35(2): 173-181. DOI: 10.12173/j.issn.1005-0698.202510009.[Article in Chinese]

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Abstract

Objective  To evaluate the adverse event and its potential causes associated with extracorporeal blood circuit during clinical use, providing recommendations for the safe clinical use of medical devices.

Methods  A systematic search was conducted across PubMed, Embase, Web of Science, the Cochrane Library, and Chinese databases including SinoMed, CNKI, VIP, and WanFang Data. The search period was from 1 January 2010 to 25 July 2025. The study collected adverse events associated with the clinical application of extracorporeal circulation blood circuits in blood purification devices, summarizing the types and causes of these adverse events. To further characterize device-related risks, pharmacovigilance signal detection was performed on the contemporaneous U.S. FDA MAUDE database utilizing three disproportionality analysis methods: the reporting odds ratio (ROR), the Bayesian confidence propagation neural network (BCPNN), and the gamma-Poisson shrinker (GPS).

Results  A total of 9 articles were included. The primary risks identified during clinical use of the extracorporeal blood circuit were connection-related issues, including connection failure, difficult separation, poor sealing, disconnection, and accessory detachment. Literature analysis revealed that product quality issues were the primary cause of device failure, accounting for 46.6% of reported incidents; operational factors were the second most common cause. In the MAUDE database, 642 device adverse event records and 523 patient adverse event records were retrieved, signal detection identified 13 positive signals.

Conclusions  Connection problems represent the most frequent type of device-related adverse event associated with extracorporeal blood circuits. These are mainly attributable to product quality defects, with technical operation being another significant contributing factor. Manufacturers should strengthen quality control across the entire production-to-transportation process, improve packaging design to prevent component detachment, and include clear warnings regarding secondary fastening checks. Healthcare staff should develop individualized treatment protocols and continuously enhance operational proficiency in blood purification techniques to collectively reduce the incidence of related adverse events.

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