美国MAUDE数据库一次性输血器不良事件监测数据分析  

Analysis of Adverse Event Report for Blood Transfusion Device in MAUDE Database

作　　者：王丽[1] 王新茹 夏兵 马雪皎[1] 杨雪[1] 王干一 陈晓博 刘曦朦 WANG Li;WANG Xin-ru;XIA Bing;MA Xue-jiao;YANG Xue;WANG Gan-yi;CHEN Xiao-bo;LIU Xi-meng(Center for Food and Drug evaluation of Henan Henan Zhengzhou 450018)

机构地区：[1]河南省食品药品评价中心

出　　处：《中国医疗器械信息》2019年第19期31-32,52,共3页China Medical Device Information

摘　　要：目的:分析总结一次性输血器的不良事件发生情况及问题,为进一步提高其使用安全提出建议。方法:对2015年~2019年美国食品药品监督管理局MAUDE数据库中317例一次性输血器的不良事件报告进行统计分析。结果:一次性输血器有关的器械故障主要表现为漏液、断裂、堵塞等,主要原因为输血器管路连接处故障、材料质量问题、操作不当、滤网堵塞等。结论:监管部门和有关单位应加强风险责任意识,建立健全监测相关的工作制度,保障公众使用一次性输血器的安全。Ojective: Collection and analysis of adverse event report for blood transfusion device in MAUDE database, so as to provide effective resolutions for safety use. Method: By retrieving published MDR cases induced by blood transfusion device in FDA MAUDE database, 623 cases of adverse events in MAUDE database from 2015 to 2019 were obtained, screened and analyzed. Result: The device failure related to the blood transfusion device mainly manifests as fluid leak, break, blockage, etc. The main reasons are connector failure, material deformation, improper operation, filterblockage. Conclusion: The public safety of blood transfusion device use can be ensued according to perfecting related laws, establishing and regulating the MDR monitor system and strengthening the responsibility of authority, manufacturers, suppliers and medical institutions.

关 键 词：一次性输血器 医疗器械不良事件监测 风险因素 数据分析 

分 类 号：TH789[机械工程—仪器科学与技术]