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

Model Number	PERFUSION PACK- 046012200
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Upon priming of cardiopulmonary bypass of the circuit, perfusionist notices crystalloid dripping from arterial temperature port.That port is not a designed exit point.Perfusionist changed out the oxygenator, reprimed.Performed pre-bypass checklist and proceeded with case.

• Brand Name: PERFUSION PACK
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 19770891
• Report Number: 19770891
• Device Sequence Number: 8604735
• Product Code: DWE
• UDI-Device Identifier: 00803622152832
• UDI-Public: (01)00803622152832
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/18/2024
• Report Date (Section F): 06/18/2024

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
• Operator of Device: Other
• Device Model Number: PERFUSION PACK- 046012200
• Device Lot Number: 2303200025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/18/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/18/2024