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

Model Number	PERFUSION PACK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
While setting up for a case, the perfusionist noted a leak coming from the cardioplegia disposable delivery line.After trying to troubleshoot, it was determined that the disposable was faulty and needed to be changed out.The cardioplegia circuit was replaced with a new one and case preparation was continued.All events occurred prior to the patient entering the room.

• Brand Name: PERFUSION PACK
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 16742542
• Report Number: 16742542
• Device Sequence Number: 15135144
• Product Code: DWE
• UDI-Device Identifier: 00803622151736
• UDI-Public: 00803622151736
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/07/2023
• Report Date (Section F): 04/07/2023

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
• Operator of Device: Health Professional
• Device Model Number: PERFUSION PACK
• Device Lot Number: 2303000028
• 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: 04/14/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Race: White
• Date Report Sent to FDA: 04/07/2023