MAUDE Adverse Event Report: LIVANOVA USA, INC. SMART PERFUSION PACK, INSPIRE 8FS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Lot Number 1916300046

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/16/2019

Event Type  malfunction  

Event Description

The perfusionist opened up the tubing pack for a pump set up, and the arterial pressure line connecter at the oxygenator was broken.

• Brand Name: SMART PERFUSION PACK, INSPIRE 8FS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 9877733
• MDR Text Key: 184855395
• Report Number: 9877733
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/25/2020,08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 1916300046
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2020
• Type of Device Usage: N
• Patient Sequence Number: 1