MAUDE Adverse Event Report: MEDTRONIC, INC. AFFINITY FUSION

Model Number BB811

Device Problem Ambient Temperature Problem (2878)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/03/2016

Event Type  Injury  

Event Description

After bypass initiated, the team noticed the blood was not red.Bypass stopped and attempted to troubleshoot.Bypass restarted but oxygenator needed to be exchanged.Case proceeded without incident.

• Brand Name: AFFINITY FUSION
• Type of Device: AFFINITY FUSION
• Manufacturer (Section D): MEDTRONIC, INC.; minneapolis MN 55432
• MDR Report Key: 6112681
• MDR Text Key: 60569006
• Report Number: MW5066102
• Device Sequence Number: 1
• Product Code: DTZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 11/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BB811
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention