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

Model Number 96670-125

Patient Problem Insufficient Information (4580)

Event Date 10/06/2023

Event Type  malfunction  

Event 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
• 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: 18064320
• MDR Text Key: 327263274
• Report Number: 18064320
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00763000060633
• UDI-Public: (01)00763000060633
• 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: 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
• Device Operator: 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
• Date Report Sent to FDA: 10/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 11/03/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24455 DA
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Race: White