基于美国FDA MADUE和国家医疗器械不良事件监测信息系统数据库输血输液加温器不良事件分析

Analysis of Adverse Events of Blood Transfusion Infusion Heater Based on US FDA MADUE and National Medical Device Adverse Event Monitoring Information System Database

目的挖掘输血输液加温器使用风险,为国家“十四五”输血输液加温器重点监测及医疗机构正确和安全使用输血输液加温器提供信息和参考。方法对2018—2022年美国FDA MADUE和2019—2022年国家医疗器械不良事件监测信息系统数据库中1303条输血输液加温器不良事件报告进行整理,就涉及的产品品牌、型号、上报人对不良事件的陈述、医疗器械上市许可持有人对不良事件可能原因的反馈信息进行分析,并结合不同品牌输血输液加温器的设计原理,对输血输液加温器的使用风险进行初步探讨。结果1303条医疗器械不良事件报告中,事件后果主要是设备故障、患者严重伤害、患者死亡。其中设备故障1280条,占98.23%;患者严重伤害10条,占0.77%;患者死亡13条,约占1.00%。主要现象有死亡、心脏骤停、低血压、电击、低体温、皮肤烧伤、无法开机、黑屏、不加温、加温效果差、过热或超温报警、输液管内出现气泡、液体漏液、焦糊味、输血输液流量不足、报警失效或无报警等。结论生产企业要加强输血输液加温器产品的研发升级,完善产品功能,提高其性能及安全性;医疗机构等使用单位要加强输血输液加温器的使用和维护保养培训,并加强输血输液加温器的临床使用效果研究,为医院安全用械和生产企业产品研发升级提供参考和信息。

Objective To explore the risk of using blood transfusion infusion heater,provide information and reference for the key monitoring of national“14th Five-Year Plan”blood transfusion infusion heater and the correct and safe use of blood transfusion infusion heater in medical institutions.Methods A total of 1303 adverse event reports of blood transfusion infusion heater were collated from the FDA MADUE of USA during 2018-2022 and the National Medical Device Adverse Event Monitoring Information System Database during 2019-2022.Based on the analysis of the product brands,models,the reports of adverse events,and the feedback information of the medical device marketing authorization holders on the possible causes of adverse events,and combined with the design principles of different brands of blood transfusion infusion heater,the use risk of blood transfusion infusion heater was preliminatively discussed.Results Among 1303 reports of medical device adverse events,the main consequences were equipment failure,serious injury and death of patients.Among them,1280 were equipment failures,accounting for 98.23%;10 patients were seriously injured,accounting for 0.77%;13 patients died,accounting for 1.00%.The main phenomena include death,cardiac arrest,hypotension,electric shock,hypothermia,skin burn,inability to turn on,black screen,no heating,poor heating effect,overheating or overtemperature alarm,bubbles in the infusion tube,liquid leakage,burnt taste,insufficient blood transfusion and infusion flow,alarm failure or no alarm.Conclusion Manufacturers should strengthen the research and development and upgrade of blood transfusion infusion heater,improve its function,performance and safety.Medical institutions and other users should train on the use and maintenance of blood transfusion infusion heater,and strengthen the clinical use effect research of it,so as to provide reference and information for safety of hospital equipment and product development and upgrading of production enterprises.