MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Device Problem No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

During a cardiac bypass the cardioplegia line wound not flow.The perfusionist removed the line, and placed a new line.

• Brand Name: MEDTRONIC
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 16609719
• MDR Text Key: 311959554
• Report Number: 16609719
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19710 DA
• Patient Sex: Male