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

Model Number	CARDIOPLEGIA PACK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Upon priming the pump and performing the pre-bypass checklist, cardioplegia circuit was pressure checked per protocol.Upon building pressure, the bottom of the heater/ cooler exchanger was leaking.Component was changed out, new circuit was primed and checked.

• Brand Name: CARDIOPLEGIA PACK
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 17735369
• Report Number: 17735369
• Device Sequence Number: 17800679
• Product Code: DWE
• UDI-Device Identifier: 00803622150548
• UDI-Public: (01)00803622150548
• 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): 09/07/2023
• Report Date (Section F): 09/07/2023

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: CARDIOPLEGIA PACK
• Device Catalogue Number: 627391402
• Device Lot Number: 2304800041
• 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: 09/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/13/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 09/07/2023