MAUDE Adverse Event Report: LIVANOVA USA, INC. SMART PERFUSION PACK - ECMO CIRCUIT; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number 627257503

Device Problem Connection Problem (2900)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Ecmo circuits are not connected at the bonded areas.We have found a circuit that was supposed to have pre-bonded areas that is unconnected.We have contacted the company who is actively working on investigating and identifying the root of the problem.

• Brand Name: SMART PERFUSION PACK - ECMO CIRCUIT
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 15419688
• MDR Text Key: 300060337
• Report Number: MW5112038
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Model Number: 627257503
• Device Lot Number: 2135000040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1