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

Model Number	CA-40020
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Physician identified that the suction device was leaking blood after attempting to prime the cardioplegia lines and suction device.We were on bypass but had not yet clamped the aorta.

• Brand Name: CARDIOPLEGIA SOLUTION ADMINISTRATION ADAPTOR
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 12614545
• Report Number: 12614545
• Device Sequence Number: 1205311
• Product Code: DWF
• UDI-Device Identifier: 00803622103735
• UDI-Public: (01)00803622103735
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 10/01/2021
• Report Date (Section F): 10/07/2021

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
• Operator of Device: Health Professional
• Device Model Number: CA-40020
• Device Lot Number: 2109500068
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 90
• Date Report Sent to FDA: 10/07/2021