Evaluating Adverse Events Associated With ECMO Devices Using MAUDE Database: Monitoring the Lifeline
Author(s)
Sannidhi Prabhu, PharmD1, Adusumilli Pramod Kumar, Ph.D2, Crispin Dona J, PharmD3.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India, 3M S Ramaiah University Of Applied Sciences, Bengaluru, India.
1Student, M S Ramaiah University Of Applied Sciences, Bengaluru, India, 2M S Ramaiah University Of Applied Sciences, Bangalore, India, 3M S Ramaiah University Of Applied Sciences, Bengaluru, India.
OBJECTIVES: Extracorporeal membrane oxygenation (ECMO) is a life-supporting modality used in cases of severe cardiac or respiratory failure unresponsive to conventional treatments. The ECMO system consists of essential components such as cannulas, pumps, oxygenators, and tubing that externally oxygenate blood, supporting heart and lung function. This study aims to investigate adverse events (AEs) associated with ECMO devices using data mining techniques applied to the FDA MAUDE database.
METHODS: A retrospective review of the FDA MAUDE database was performed to identify adverse events related to ECMO devices from January 2021 to May 2025. Using relevant FDA product codes, reports on components like cannulas, pumps, oxygenators, and tubing were extracted. Descriptive statistics identified event frequency, patterns, and trends for informed clinical safety practices.
RESULTS: An analysis of 1260 cases from the specified period revealed that the most frequently reported event type was malfunction (95%) majorly in the cardiopulmonary bypass, blood oxygenator device. This class III device (ECMO) is associated with various device problems such as device dislodgement (54%), fluid/Blood leak (52%), fracture (38%), communication/transmission problems (23%), infusion/flow problem (19%) and air/gas in device (7.9%).Patient complications observed in the dataset were largely due to hematoma; swelling/edema (14.6%), perforation (12%), haemorrhage/bleeding(9.79%), air embolism (8%), bradycardia and cardiac arrest (6%), multiple organ failure (2%) and hypotension (1.28%).
CONCLUSIONS: ECMO is a vital life-saving intervention in critical care. MAUDE database findings show that while effective, ECMO devices carry risks such as malfunctions and patient complications. These events are generally manageable, highlighting the need for ongoing monitoring, adherence to best practices, and informed use to ensure patient safety and optimal outcomes.
METHODS: A retrospective review of the FDA MAUDE database was performed to identify adverse events related to ECMO devices from January 2021 to May 2025. Using relevant FDA product codes, reports on components like cannulas, pumps, oxygenators, and tubing were extracted. Descriptive statistics identified event frequency, patterns, and trends for informed clinical safety practices.
RESULTS: An analysis of 1260 cases from the specified period revealed that the most frequently reported event type was malfunction (95%) majorly in the cardiopulmonary bypass, blood oxygenator device. This class III device (ECMO) is associated with various device problems such as device dislodgement (54%), fluid/Blood leak (52%), fracture (38%), communication/transmission problems (23%), infusion/flow problem (19%) and air/gas in device (7.9%).Patient complications observed in the dataset were largely due to hematoma; swelling/edema (14.6%), perforation (12%), haemorrhage/bleeding(9.79%), air embolism (8%), bradycardia and cardiac arrest (6%), multiple organ failure (2%) and hypotension (1.28%).
CONCLUSIONS: ECMO is a vital life-saving intervention in critical care. MAUDE database findings show that while effective, ECMO devices carry risks such as malfunctions and patient complications. These events are generally manageable, highlighting the need for ongoing monitoring, adherence to best practices, and informed use to ensure patient safety and optimal outcomes.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
RWD78
Topic
Clinical Outcomes, Epidemiology & Public Health, Real World Data & Information Systems
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Injury & Trauma, No Additional Disease & Conditions/Specialized Treatment Areas, Sensory System Disorders (Ear, Eye, Dental, Skin)