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

Model Number	96670-125
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient in cath lab for veno arterial ecmo (extracorporeal membrane oxygenation) cannulation.Venous cannula opened and placed by surgeon without issue.Upon connection to ecmo circuit, continuous air noted in connection with clamps in place.Circuit disconnected and reconnected multiple times without resolution.Further inspection into cannula, cannula removed, and new cannula placed.Patient connected to ecmo circuit with no further issues.

• Brand Name: BIO-MEDICUS
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 18064320
• Report Number: 18064320
• Device Sequence Number: 7468885
• Product Code: DWF
• UDI-Device Identifier: 00763000060633
• UDI-Public: (01)00763000060633
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/24/2023
• Report Date (Section F): 10/24/2023

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
• Operator of Device: Health Professional
• Device Model Number: 96670-125
• Device Lot Number: 226837167
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White
• Date Report Sent to FDA: 10/24/2023