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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. AFFINITY FUSION OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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MEDTRONIC, INC. AFFINITY FUSION OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number BB811
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Air Embolism (1697); Death (1802); Edema (1820)
Event Date 01/31/2019
Event Type  Death  
Event Description
My husband had quadruple bypass surgery. During the operation, air had invaded the heart - lung bypass circuit. Air was found in his aorta, his grafts, the arterial line, and the reservoir. A ct of his brain revealed massive, diffuse cerebral edema secondary to air embolism. We terminated life support on (b)(6) 2019, and he died.
 
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Brand NameAFFINITY FUSION OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MEDTRONIC, INC.
MDR Report Key8687260
MDR Text Key147659833
Report NumberMW5087240
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 05/29/2019
4 Devices were Involved in the Event: 1   2   3   4  
1 Patient was Involved in the Event
Date FDA Received06/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberBB811
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/10/2019 Patient Sequence Number: 1
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