Production Research and Risk Factor Analysis of Transfusion and Infusion Warmer Based on Real-World Data.
10.12455/j.issn.1671-7104.240688
- Author:
Hongfeng BI
1
;
Yonggang WANG
2
;
Zhendong WANG
3
;
Yuan FU
1
;
Huifang NIU
4
Author Information
1. Medical Equipment Department, Shengli Oilfield Central Hospital, Dongying,
2. Dongying Adverse Drug Reaction and Medical Device Adverse Event Monitoring Center, Dongying,
3. Drug Testing and Evaluation Section, Weihai Institute for Food and Drug Control, Weihai,
4. Shandong Adverse Drug Reaction Monitoring Center, Jinan,
- Publication Type:Journal Article
- Keywords:
adverse events;
real-world data;
research;
transfusion and infusion warmer
- MeSH:
Blood Transfusion/instrumentation*;
Risk Factors;
Quality Control;
Humans;
Risk Management;
Equipment Failure
- From:
Chinese Journal of Medical Instrumentation
2025;49(4):466-472
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To investigate the transfusion and infusion warmer manufacturers, combine the use failures to analyze adverse events, and provide support for enterprise risk management and clinical safe use.
METHODS:The sentinels from 7 manufacturing enterprises and 11 medical institutions that participated in Shandong Province's key monitoring program during the "14th Five-Year Plan" period were targeted. This was done by understanding the equipment's principles, structures, and quality control. Additionally, real-world data from January 2019 to December 2023 were collected to count adverse events.
RESULTS:During production, there are risks in switching power supply stability and solder joint firmness. Fifteen kinds of faults occurred during use, and common faults such as inability to heat, unable to turn on the machine, and bubbles in the infusion tube accounted for more than 80%.
CONCLUSION:There are many risk points and failures for transfusion and infusion warmers, so enterprises should improve processes and quality control to address risks, and medical institutions should formulate specifications and maintenance plans to provide targeted theoretical basis for supervision.
