MAUDE Adverse Event Report: MC3 INC. MC3 ECMO OXYGENATOR; OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS

Model Number	48135
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a mc3 nautilus extracorporeal membrane oxygenation (ecmo) oxygenator, it was reported that the heat exchanger was not working.The device was replaced.There was no adverse patient effect associated with this event.Medtronic received an additional device for analysis; however, it was confirmed that the customer did not want to use the second device since it has the same lot number as the first device that was not working.The second device was not used or opened.Medtronic received additional information that the patient was on ecmo for about 12 hours prior to the customer noticing the heat exchanger was not working.The customer said they tested the flow through the oxygenator water path before initiating.The device was replaced after about 12 hours.
Additional Manufacturer Narrative
This report is being submitted as part of remediation activities associated with capa#: 643143, which is addressing mdr reporting guidance from fdas 1995 preamble, which ensures complaints related to corrections and recalls which were previously reported to fda under 21 cfr 806 are now reported as mdrs; this is not a new malfunction/event.Device evaluation summary: visual inspection of the 1 returned used device shows no outward signs of any damage.Reason for return was undetermined.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: MC3 ECMO OXYGENATOR
• Common Device Name: OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS
• Manufacturer (Section D): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• Manufacturer (Section G): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 22435964
• Report Number: 3011468686-2025-00045
• Device Sequence Number: 4708272
• Product Code: BYS
• UDI-Device Identifier: 10854916006871
• UDI-Public: (01)10854916006871(17)250228(10)2302190
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K191935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/08/2025

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 Expiration Date: 02/28/2025
• Device Model Number: 48135
• Device Catalogue Number: 48135
• Device Lot Number: 2302190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2023
• Initial Report FDA Received Date: 07/08/2025
• Date Device Manufactured: 02/28/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1309-2024
• Patient Sequence Number: 1
• Patient Sex: Unknown