Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for Patient- and Circuit-Related Adverse Events Involving Extracorporeal Membrane Oxygenation.
Analysis of the Food and Drug Administration Manufacturer and User Facility Device Experience Database for Patient- and Circuit-Related Adverse Events Involving Extracorporeal Membrane Oxygenation.
- 2020
Available in print through MWHC library: 2002 - present
BACKGROUND/PURPOSE: We assessed commonly reported patient- and circuit-related adverse events involving extracorporeal membrane oxygenation (ECMO) devices by analyzing post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. ECMO is a rescue therapy for critically ill patients requiring oxygenation and cardiopulmonary support. Key configurations include veno-venous (VV) ECMO for respiratory support and veno-arterial (VA) ECMO for cardio-respiratory support. Robust data on the most commonly reported complications associated with ECMO therapy are limited. CONCLUSIONS: Analysis of the MAUDE database demonstrates that in real-world practice, ECMO devices are associated with important complications. With broadened global utilization of ECMO devices, standard complication and failure reporting policies may improve patient selection, operator proficiency, and existing device technology. METHODS/MATERIALS: The MAUDE database was queried from January 1, 2009, through March 31, 2019, yielding 93 reports. After excluding duplicate reports, 82 reports were included in the final analysis. RESULTS: Percentages represent the proportion of total submitted MAUDE reports on ECMO. Of the reported cases, 24 were VV-ECMO, 8 were VA-ECMO, and the remainder were unspecified. The most commonly reported patient-related adverse events included hemodynamic decompensation of patients (12.2%), death (12.2%), atrial perforation (7.3%), and bleeding (7.3%). The most commonly reported failure modes were in the following circuit components: mechanical pump (19.5%, mostly due to technical failure or clots), membrane oxygenator (19.5%, mostly due to tear in the membrane or temperature probe), and access cannulae (18.3%, mostly due to structural damage). SUMMARY: An analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience database demonstrates that in real-world practice, extracorporeal membrane oxygenation devices are associated with serious complications. The most commonly reported patient-related adverse events were hemodynamic decompensation of patients and death, and the most commonly reported failure modes were in the device's mechanical pump and membrane oxygenator. Copyright (c) 2019 Elsevier Inc. All rights reserved.
English
1878-0938
10.1016/j.carrev.2019.11.011 [doi] S1553-8389(19)30757-2 [pii]
*Device Approval
*Extracorporeal Membrane Oxygenation/ae [Adverse Effects]
*Extracorporeal Membrane Oxygenation/is [Instrumentation]
*Heart Diseases/th [Therapy]
*Oxygenators, Membrane/ae [Adverse Effects]
*Product Surveillance, Postmarketing
*Respiratory Insufficiency/th [Therapy]
*United States Food and Drug Administration
Databases, Factual
Equipment Failure
Extracorporeal Membrane Oxygenation/mo [Mortality]
Heart Diseases/di [Diagnosis]
Heart Diseases/mo [Mortality]
Heart Diseases/pp [Physiopathology]
Hemodynamics
Humans
Patient Safety
Respiratory Insufficiency/di [Diagnosis]
Respiratory Insufficiency/mo [Mortality]
Respiratory Insufficiency/pp [Physiopathology]
Risk Assessment
Risk Factors
Treatment Failure
United States
MedStar Heart & Vascular Institute
Journal Article
Available in print through MWHC library: 2002 - present
BACKGROUND/PURPOSE: We assessed commonly reported patient- and circuit-related adverse events involving extracorporeal membrane oxygenation (ECMO) devices by analyzing post-marketing surveillance data from the Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database. ECMO is a rescue therapy for critically ill patients requiring oxygenation and cardiopulmonary support. Key configurations include veno-venous (VV) ECMO for respiratory support and veno-arterial (VA) ECMO for cardio-respiratory support. Robust data on the most commonly reported complications associated with ECMO therapy are limited. CONCLUSIONS: Analysis of the MAUDE database demonstrates that in real-world practice, ECMO devices are associated with important complications. With broadened global utilization of ECMO devices, standard complication and failure reporting policies may improve patient selection, operator proficiency, and existing device technology. METHODS/MATERIALS: The MAUDE database was queried from January 1, 2009, through March 31, 2019, yielding 93 reports. After excluding duplicate reports, 82 reports were included in the final analysis. RESULTS: Percentages represent the proportion of total submitted MAUDE reports on ECMO. Of the reported cases, 24 were VV-ECMO, 8 were VA-ECMO, and the remainder were unspecified. The most commonly reported patient-related adverse events included hemodynamic decompensation of patients (12.2%), death (12.2%), atrial perforation (7.3%), and bleeding (7.3%). The most commonly reported failure modes were in the following circuit components: mechanical pump (19.5%, mostly due to technical failure or clots), membrane oxygenator (19.5%, mostly due to tear in the membrane or temperature probe), and access cannulae (18.3%, mostly due to structural damage). SUMMARY: An analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience database demonstrates that in real-world practice, extracorporeal membrane oxygenation devices are associated with serious complications. The most commonly reported patient-related adverse events were hemodynamic decompensation of patients and death, and the most commonly reported failure modes were in the device's mechanical pump and membrane oxygenator. Copyright (c) 2019 Elsevier Inc. All rights reserved.
English
1878-0938
10.1016/j.carrev.2019.11.011 [doi] S1553-8389(19)30757-2 [pii]
*Device Approval
*Extracorporeal Membrane Oxygenation/ae [Adverse Effects]
*Extracorporeal Membrane Oxygenation/is [Instrumentation]
*Heart Diseases/th [Therapy]
*Oxygenators, Membrane/ae [Adverse Effects]
*Product Surveillance, Postmarketing
*Respiratory Insufficiency/th [Therapy]
*United States Food and Drug Administration
Databases, Factual
Equipment Failure
Extracorporeal Membrane Oxygenation/mo [Mortality]
Heart Diseases/di [Diagnosis]
Heart Diseases/mo [Mortality]
Heart Diseases/pp [Physiopathology]
Hemodynamics
Humans
Patient Safety
Respiratory Insufficiency/di [Diagnosis]
Respiratory Insufficiency/mo [Mortality]
Respiratory Insufficiency/pp [Physiopathology]
Risk Assessment
Risk Factors
Treatment Failure
United States
MedStar Heart & Vascular Institute
Journal Article