197例输液泵不良事件的统计与分析

Statistics and analysis of adverse events of medical infusion pump in 197 cases

医用输液泵液体输注功能的安全性和精准性关系到患者的生命安全和医疗质量,其质量监控至关重要,为了有效提高国内输液泵的产品质量,指导临床合理使用输液泵,避免不良事件的发生,本文对2019年1月至12月国家医疗器械不良事件监测信息系统数据库中收集到的各级医疗机构上报的197例输液泵不良事件报告开展回顾性研究,对其中器械故障、对患者的主要伤害、事件后果等内容进行归类、统计和分析,以便为输液泵的临床安全使用以及生产企业改进产品质量与性能提供参考。

The safety and accuracy of the liquid infusion function of medical infusion pump is directly related to patients’life safety and medical quality,so that its quality control is of great importance.In order to effectively improve the product quality of domestic infusion pump,guide the rational use of infusion pumps in clinic and avoid the occurrence of adverse events,197 adverse events of infusion pumps reported by medical institutions were collected from the National Medical Device Adverse Event Monitoring Information System database from January to December,2019 and retrospectively analyzed,in which the device failures,major injuries to patients and their consequences were classified and statistically analyzed,so as to provide references for the clinical safe use of medical infusion pump and the improvement of the quality and performance of the product.