MAUDE Adverse Event Report: SORIN GROUP ITALIA VENO-VENOUS PROTEK DUO+ CANNULA; DUAL LUMEN ECMO CANNULA

Model Number	31FR
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.F14: updated manufacturer name and address to sorin group italia [9680841].H11: through follow-up communications, livanova learned that the cannula was used for five (5) days.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 us received report of a protekduo+ cannula which was found cracked during usage.Reportedly, air intake occurred and support was reconfigured.No further issue occurred.

• Brand Name: VENO-VENOUS PROTEK DUO+ CANNULA
• Common Device Name: DUAL LUMEN ECMO CANNULA
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• MDR Report Key: 25031620
• Report Number: 1718850-2026-10004
• Device Sequence Number: 21365710
• Product Code: PZS
• UDI-Device Identifier: 08033178019422
• UDI-Public: (01)08033178019422(17)280826(11)250826(240)5150-5131(10)489078
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 31FR
• Device Catalogue Number: 5150-5131
• Device Lot Number: 489078
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/10/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/29/2026
• Date Device Manufactured: 08/26/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown