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

Model Number CB96570-019

Device Problem Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/08/2021

Event Type  malfunction  

Event Description

Ecmo cannuala failed.19 fr biomedicus cannula arterial placed and then noted to have bleeding from cannula.The bleeding required changing of the cannula by surgeons.Patient required cpr for brief time while switching cannula.

• Brand Name: BIO-MEDICUS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic pkwy; minneapolis MN 55432
• MDR Report Key: 11472581
• MDR Text Key: 239423295
• Report Number: 11472581
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/09/2021

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: No Information
• Device Model Number: CB96570-019
• Device Catalogue Number: CB96570-019
• Device Lot Number: 219437606
• 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: 03/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1