MAUDE Adverse Event Report: SPECTRUM / QURA S. R. L. ECMO CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Lot Number E002593

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Insufficient Information (4580)

Event Date 12/20/2022

Event Type  malfunction  

Event Description

Ecmo cannula fracture resulting in minor blood leak and surgical procedure for replacement.The fracture occurred at the point of flexion in the cannula between points of suture fixation.The cannula was fixed by suture at the point of insertion near the right lateral neck and also in front of the right ear.The cannula fracture occurred at a mid-point in between.The patient's forward head movements would create the flexion.The patient was very active.

• Brand Name: ECMO CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SPECTRUM / QURA S. R. L.
• MDR Report Key: 16148589
• MDR Text Key: 307289411
• Report Number: MW5114294
• Device Sequence Number: 1
• 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: 01/10/2023

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 Lot Number: E002593
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 17 YR
• Patient Sex: Prefer Not To Disclose