MAUDE Adverse Event Report: PERFUSION SYSTEMS EOPA 3D VENTED ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	78220
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
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
(pli10) it was reported that condensation was found in the packaging of the eopa 3d arterial cannula, rendering it non-sterile and unusable.(pli20) additionally, foreign material was present in another cannula from the same batch.The customer noticed these issues upon opening the packaging.The device was replaced.There was no patient involved.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection was performed at 18 inches with an unaided eye per medtronic grand rapids document mi-qs-000194.There is no evidence of loose fm inside either package.Reason for return was not confirmed.Additional info b5: medtronic received additional information that the sterile barrier was still sealed when the fm was identified.Additional info d9: updated the device evaluation availability and device return date additional info h6: updated the annex b and annex c codes 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.
Additional Manufacturer Narrative
Correction d4: unique identifier (udi) # format updated.Correction h11: updated device.Evaluation summary: visual inspection was performed at 18 inches with an unaided eye.There is evidence of a couple of pieces of loose foreign material inside the peel pouch.Reason for return was confirmed.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.

• Brand Name: EOPA 3D VENTED ARTERIAL 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: 21907731
• Report Number: 2184009-2025-00577
• Device Sequence Number: 8712846
• Product Code: DWF
• UDI-Device Identifier: 00763000946845
• UDI-Public: (01)00763000946845(17)271002(10)2024100224(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K150422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2025

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
• Device Model Number: 78220
• Device Catalogue Number: 78220
• Device Lot Number: 2024100224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Supplement Date Received by Manufacturer: 05/06/2025; 07/24/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 05/30/2025; 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/02/2024
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown