MARC details
| 000 -LEADER |
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| fixed length control field |
05344nam a22008057a 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
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| fixed length control field |
191219s20202020 xxu||||| |||| 00| 0 eng d |
| 022 ## - INTERNATIONAL STANDARD SERIAL NUMBER |
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| International Standard Serial Number |
1878-0938 |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
10.1016/j.carrev.2019.11.011 [doi] |
| 024 ## - OTHER STANDARD IDENTIFIER |
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| Standard number or code |
S1553-8389(19)30757-2 [pii] |
| 040 ## - CATALOGING SOURCE |
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| Original cataloging agency |
Ovid MEDLINE(R) |
| 099 ## - LOCAL FREE-TEXT CALL NUMBER (OCLC) |
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| PMID |
31767523 |
| 245 ## - TITLE STATEMENT |
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| Title |
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. |
| 251 ## - Source |
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| Source |
Cardiovascular Revascularization Medicine. 21(2):230-234, 2020 02. |
| 252 ## - Abbreviated Source |
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| Abbreviated source |
Cardiovasc Revasc Med. 21(2):230-234, 2020 02. |
| 252 ## - Abbreviated Source |
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| Former abbreviated source |
Cardiovasc Revasc Med. 2019 Nov 20 |
| 253 ## - Journal Name |
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| Journal name |
Cardiovascular revascularization medicine : including molecular interventions |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Year |
2020 |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. |
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| Manufacturer |
FY2020 |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
aheadofprint |
| 265 ## - SOURCE FOR ACQUISITION/SUBSCRIPTION ADDRESS [OBSOLETE] |
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| Publication status |
ppublish |
| 266 ## - Date added to catalog |
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| Date added to catalog |
2019-12-17 |
| 268 ## - Previous citation |
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| -- |
Cardiovascular Revascularization Medicine. 2019 Nov 20 |
| 501 ## - WITH NOTE |
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| Local holdings |
Available in print through MWHC library: 2002 - present |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
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. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
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. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
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. |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
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). |
| 520 ## - SUMMARY, ETC. |
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| Abstract |
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. |
| 546 ## - LANGUAGE NOTE |
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| Language note |
English |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Device Approval |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Extracorporeal Membrane Oxygenation/ae [Adverse Effects] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Extracorporeal Membrane Oxygenation/is [Instrumentation] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Heart Diseases/th [Therapy] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Oxygenators, Membrane/ae [Adverse Effects] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Product Surveillance, Postmarketing |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*Respiratory Insufficiency/th [Therapy] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
*United States Food and Drug Administration |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Databases, Factual |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Equipment Failure |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Extracorporeal Membrane Oxygenation/mo [Mortality] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Heart Diseases/di [Diagnosis] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Heart Diseases/mo [Mortality] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Heart Diseases/pp [Physiopathology] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Hemodynamics |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Humans |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Patient Safety |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Respiratory Insufficiency/di [Diagnosis] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Respiratory Insufficiency/mo [Mortality] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Respiratory Insufficiency/pp [Physiopathology] |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Risk Assessment |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Risk Factors |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
Treatment Failure |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM |
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| Topical term or geographic name entry element |
United States |
| 651 ## - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
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| Institution |
MedStar Heart & Vascular Institute |
| 657 ## - INDEX TERM--FUNCTION |
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| Medline publication type |
Journal Article |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Ahmad, Sarah Aftab |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Bernardo, Nelson L |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Chen, Yuefeng |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Edelman, J James |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Hashim, Hayder |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Javed, Hasan |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Khalid, Nauman |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Musallam, Anees |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Rogers, Toby |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Shlofmitz, Evan |
| 700 ## - ADDED ENTRY--PERSONAL NAME |
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| Local Authors |
Waksman, Ron |
| 790 ## - Authors |
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| All authors |
Ahmad SA, Bernardo NL, Chen Y, Edelman JJ, Hashim H, Javed H, Khalid N, Musallam A, Rogers T, Shlofmitz E, Waksman R |
| 856 ## - ELECTRONIC LOCATION AND ACCESS |
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| DOI |
<a href="https://dx.doi.org/10.1016/j.carrev.2019.11.011">https://dx.doi.org/10.1016/j.carrev.2019.11.011</a> |
| Public note |
https://dx.doi.org/10.1016/j.carrev.2019.11.011 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
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| Koha item type |
Journal Article |
| Item type description |
Article |
