Oxygenator Failures During Cardiopulmonary Bypass: MAUDE Database Analysis Using Natural Language Processing
Poster #: 073
Session/Time: B
Author:
Rishab Agarwal, BS
Mentor:
Jace Bradshaw, MD
Research Type: Clinical Research
Abstract
INTRODUCTION:
Cardiopulmonary bypass (CPB) oxygenators provide essential intra-operative gas exchange. Although rare, failures can cause severe morbidity or mortality. CPB-specific analyses of the FDA's Manufacturer and User Facility Device Experience (MAUDE) database are limited.
METHODS:
We retrospectively reviewed MAUDE reports (April 2015-April 2025) of CPB oxygenator failures resulting in injury or death. ECMO events, malfunctions without harm, and duplicates were excluded. Manufacturer, device problem, and patient problem were compared between injury and death cohorts using chi-square or Fisher's exact tests. Narrative reports underwent natural language processing (TF-IDF, n-gram analysis, non-negative matrix factorization) to identify clinical themes.
RESULTS:
A total of 388 events met criteria: 279 injuries (71.9%) and 109 deaths (28.1%). Three manufacturers accounted for 88% of reports. MAQUET devices were more often associated with deaths (43.1% vs. 11.1%, p<0.001), TERUMO with injuries (60.6% vs. 22.9%, p<0.001). "Unexpected Device Operation" occurred more often in deaths (7.34% vs. 1.43%, p=0.0054), "Device Use/Human Factors" in injuries (11.83% vs. 4.59%, p=0.0356). Thromboembolic events were more frequent in deaths (9.17% vs. 3.58%, p=0.0381). NLP identified intra-operative performance/monitoring failures, hemolysis and thromboembolic events, and post-procedural evaluation/quality management as common descriptions of device failure situations.
CONCLUSION:
CPB oxygenator failures causing harm show distinct manufacturer, device problem, and outcome patterns. Sudden operational failures and thromboembolic complications are more often fatal. NLP enhances detection of clinically relevant patterns, supporting targeted safety strategies and device improvements.
Cardiopulmonary bypass (CPB) oxygenators provide essential intra-operative gas exchange. Although rare, failures can cause severe morbidity or mortality. CPB-specific analyses of the FDA's Manufacturer and User Facility Device Experience (MAUDE) database are limited.
METHODS:
We retrospectively reviewed MAUDE reports (April 2015-April 2025) of CPB oxygenator failures resulting in injury or death. ECMO events, malfunctions without harm, and duplicates were excluded. Manufacturer, device problem, and patient problem were compared between injury and death cohorts using chi-square or Fisher's exact tests. Narrative reports underwent natural language processing (TF-IDF, n-gram analysis, non-negative matrix factorization) to identify clinical themes.
RESULTS:
A total of 388 events met criteria: 279 injuries (71.9%) and 109 deaths (28.1%). Three manufacturers accounted for 88% of reports. MAQUET devices were more often associated with deaths (43.1% vs. 11.1%, p<0.001), TERUMO with injuries (60.6% vs. 22.9%, p<0.001). "Unexpected Device Operation" occurred more often in deaths (7.34% vs. 1.43%, p=0.0054), "Device Use/Human Factors" in injuries (11.83% vs. 4.59%, p=0.0356). Thromboembolic events were more frequent in deaths (9.17% vs. 3.58%, p=0.0381). NLP identified intra-operative performance/monitoring failures, hemolysis and thromboembolic events, and post-procedural evaluation/quality management as common descriptions of device failure situations.
CONCLUSION:
CPB oxygenator failures causing harm show distinct manufacturer, device problem, and outcome patterns. Sudden operational failures and thromboembolic complications are more often fatal. NLP enhances detection of clinically relevant patterns, supporting targeted safety strategies and device improvements.