MAUDE Adverse Event Report: LIVANOVA USA INC. PERFUSION TUBING SYSTEM (PTS); TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	RIO PERF SAN BENITO TX 1
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A1-a5 patient information was not provided h11 livanova arvada manufactures the perfusion tubing pack, the issue occurred in united states.Liavnova 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 report about disconnection in the arterial line where the 1/8th tubing connects to male luer of a perfusion tubing system (pts).Perfusionist stopped bypass for approximately three minutes to fix the problem.Procedure was then resumed without no complications.Reportedly, patient did not have any consequences.

• Brand Name: PERFUSION TUBING SYSTEM (PTS)
• 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: 23863605
• Report Number: 1718850-2025-90012
• Device Sequence Number: 21344214
• Product Code: DWE
• UDI-Device Identifier: 00803622149689
• UDI-Public: (01)00803622149689(17)270925(11)250925(240)627445801(10)2526800056
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: RIO PERF SAN BENITO TX 1
• Device Lot Number: 2526800056
• 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: 11/25/2025
• Supplement Date Received by Manufacturer: 04/30/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 05/28/2026
• Date Device Manufactured: 09/25/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown