Analysis of Adverse Events of Blood Transfusion Infusion Heater Based on US FDA MADUE and National Medical Device Adverse Event Monitoring Information System Database
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.
blood transfusion infusion heateradverse eventsrisk analysisFDA MADUENational Medical Device Adverse Event Monitoring Information System Database
国家科技期刊平台
NSTL
万方数据
