MAUDE Adverse Event Report: SORIN GROUP ITALIA RAP FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	23/25
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.-a.5.Patient information was not provided.H11: through follow-up communications, livanova learned about a similar event involving same cannula batch lot.Reportedly, the event occurred shortly after cannula insertion, and it was solved by replacing the cannula connector with a 3/8" 3/8" straight connector.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
Sorin group italia received a report of air intake in the venous line during readjustment of a rap femoral venous cannula.Cannula was clamped to avoid further air ingress, resulting in line damage.The event occurred during an ecmo procedure.There was no report of any patient injury.Reportedly, it is undetermined if this is an actual product problem or user error.

• Brand Name: RAP FEMORAL VENOUS CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer (Section G): SORIN GROUP ITALIA; via statale 12 nord, 86; mirandola (mo) 41037 ; IT 41037
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24981276
• Report Number: 9680841-2026-900015
• Device Sequence Number: 9481213
• Product Code: DWF
• UDI-Device Identifier: 00803622125805
• UDI-Public: (01)00803622125805(240)200-150(17)280413(10)2510400157
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K052081
• 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
• Report Date (Section B): 04/24/2026

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: 23/25
• Device Catalogue Number: 200-150
• Device Lot Number: 2510400157
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 04/13/2025
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown