MAUDE Adverse Event Report: MC3, INC. SOFT-FLOW AORTIC CANNULA

Catalog Number 5768

Device Problems Air Leak (1008); Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 09/19/2017

Event Type  malfunction  

Event Description

Aortic cannula used by cardiothoracic surgeon during open heart surgery for multi-vessel cad leaked air at the connector.This is the second occurrence we've had with this product; unfortunately the surgery team threw away the box and we were unable to retrieve, so do not have a lot number or expiration date.The catalog numbers are the same, 5768.

• Brand Name: SOFT-FLOW AORTIC CANNULA
• Type of Device: SOFT-FLOW AORTIC CANNULA
• Manufacturer (Section D): MC3, INC.; minneapolis MN 55432
• MDR Report Key: 6900088
• MDR Text Key: 87744902
• Report Number: MW5072511
• Device Sequence Number: 0
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5768
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/27/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 126