MAUDE Adverse Event Report: LIVANOVA USA, INC. CARDIOPLEGIA SOLUTION ADMINISTRATION ADAPTOR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	CA-XXXXX
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During the procedure a livanova cardioplegia adapter was used.When starting to use the device, it began to leak and then air was noticed to be in the system.Upon observation, near two of the connection on the device had tears/cuts in the tubing under the screw hubs.

• Brand Name: CARDIOPLEGIA SOLUTION ADMINISTRATION ADAPTOR
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 20770997
• Report Number: 20770997
• Device Sequence Number: 20836503
• Product Code: DWF
• UDI-Device Identifier: 00803622103797
• UDI-Public: (01)00803622103797(240)CA-81010(17)270611(10)2416300025
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2024
• Report Date (Section F): 11/19/2024

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 Model Number: CA-XXXXX
• Device Lot Number: 2416300025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Date Report Sent to FDA: 11/19/2024