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
Event or Problem Description
See initial report.
Additional Manufacturer Narrative
H11: photos were provided which confirmed the reported condition.Complaints database review revealed other 3 similar events occurred at the same customer facility, impacting the same perfusion tubing system product code.No concerning trend was highlighted for reported failure mode.Based on investigation findings, the event was traced back to an operator error in preforming the manual assembly.Manufacturing personnel re-training is required.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

• 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: 50017141
• Report Number: 1718850-2026-90010
• Device Sequence Number: 9606998
• 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
• Operator of Device: Health Professional
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown