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

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.

• Brand Name: AFFINITY FUSION OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 8687260
• MDR Text Key: 147659833
• Report Number: MW5087240
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BB811
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 67 YR
• Patient Weight: 87