MAUDE Adverse Event Report: MICHIGAN CRITICAL CARE CONSULTANTS, INC.D.B.A MC3 MC3 NAUTILUS(TM) ECMO OXYGENATOR; OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS

Model Number	48145
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Post oxygenator change out, blood leak noticed out of cap on post membrane.Pt had to be clamped off of ecmo [extracorporeal membrane oxygenation] briefly while cap changed out.Noted to have happened once before in the past.Manufacturer response for oxygenator, long term support greater than 6 hours, mc3 nautilus(tm) ecmo oxygenator (per site reporter).They will report and apologized for inconvenience.

• Brand Name: MC3 NAUTILUS(TM) ECMO OXYGENATOR
• Common Device Name: OXYGENATOR, LONG TERM SUPPORT GREATER THAN 6 HOURS
• Manufacturer (Section D): MICHIGAN CRITICAL CARE CONSULTANTS, INC.D.B.A MC3; 2555 bishop circle west; dexter MI 48130
• MDR Report Key: 23063050
• Report Number: 23063050
• Device Sequence Number: 15873199
• Product Code: BYS
• UDI-Device Identifier: 10854916006888
• UDI-Public: (01)10854916006888
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2025
• Report Date (Section F): 09/09/2025

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: 48145
• Device Catalogue Number: 48145
• Device Lot Number: 2503331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 09/16/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Date Report Sent to FDA: 09/09/2025