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

Model Number	044004302
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova usa received a report of a perfusion tubing pack which had the coloured clamps of cardioplegia delivery lines inverted.Red clamp was found on white clamp line and vice versa.The event occurred during procedure.There was no patient injury.

• Brand Name: PERFUSION TUBING PACK
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer (Section G): LIVANOVA USA INC.; 14401 w 65th way; arvada CO 80004
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24065413
• Report Number: 1718850-2026-90001
• Device Sequence Number: 10282698
• Product Code: DWE
• UDI-Device Identifier: 00803622134289
• UDI-Public: (01)00803622134289(17)270902(11)250902(240)044004302(10)2524500014
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K981613
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2026

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: 044004302
• Device Lot Number: 2524500014
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2025
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 01/14/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown