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

Catalog Number 04253

Device Problem Suction Failure (4039)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/10/2021

Event Type  malfunction  

Event Description

Elderly patient with history of cad (coronary artery disease) and recent chest pain.Procedure cabg x 3 (coronary artery bypass graft surgery).During the procedure, the hard-shell reservoir lost its suction.The device was traded out without problems.No known harm to patient.

• Brand Name: AFFINITY NT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 11874804
• MDR Text Key: 252394592
• Report Number: 11874804
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04253
• Device Lot Number: 2011260127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/25/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Weight: 112