MAUDE Adverse Event Report: LivaNova USA Inc. Perfusion Tubing System; Tubing, Pump, Cardiopulmonary Bypass

Model Number	CARDINAL GLENNON MO 6
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction

• Brand Name: Perfusion Tubing System
• 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: 50017107
• Report Number: 1718850-2026-90009
• Device Sequence Number: 21470444
• Product Code: DWE
• UDI-Device Identifier: 00803622156380
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2026

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
• Device Model Number: CARDINAL GLENNON MO 6
• Device Catalogue Number: 627473801
• Device Lot Number: 2613100054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/21/2026
• Date Device Manufactured: 05/11/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown