MAUDE Adverse Event Report: PERFUSION SYSTEMS BIOMEDICUS MULTISTAGE FEMORAL VENOUS CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	96880-025
Medical Device Problem Codes	Obstruction of Flow (2423); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during use of the bio-medicus multi-stage femoral venous cannula, the surgeon observed that the cannula material was softer at the tubing connection end compared to previous experiences with the same type of cannula.The end of the cannula kinked, resulting in obstructed venous flow.The surgeon was able to maneuver the cannula so that it was no longer kinked, allowing it to be used for the remainder of the case.The surgeon noted that the cannula appeared to be made of a different material than previously used, as prior cannulae had not kinked in this manner.The customer queried if the cannulae material has changed.No patient complications have been reported as a result of this event.Medtronic received additional information that the cannula was not heated or cooled prior to use but the patient¿s blood was heated and cooled and run through the cannula.The kink was not in the location of the sutures.Medtronic received additional information that the cannula was positioned at the femoral vein during use.The cannula was in use for 8 hours.

• Brand Name: BIOMEDICUS MULTISTAGE FEMORAL VENOUS CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22586881
• Report Number: 2184009-2025-00882
• Device Sequence Number: 9282671
• Product Code: DWF
• UDI-Device Identifier: 00763000242367
• UDI-Public: (01)00763000242367(17)280417(10)2024040564
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K052524
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/24/2025

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: 96880-025
• Device Catalogue Number: 96880-025
• Device Lot Number: 2024040564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2025
• Initial Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male