MAUDE Adverse Event Report: MC3 INC. MC3 NAUTILUS SMART ECMO OXYGENATOR; NAUTILUS OXYGENATOR

Model Number	48135
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a mc3 nautilus extra corporeal membrane oxygenation (ecmo) oxygenator, it was reported that the information on the screen would not open and it was blank.  the device was used to complete the procedure.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Analysis of the returned device revealed a minor crack on the inlet port, near the sensor board.Blood leaked through the crack and caused the electronics to malfunction.

• Brand Name: MC3 NAUTILUS SMART ECMO OXYGENATOR
• Common Device Name: NAUTILUS OXYGENATOR
• 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: tanya pockrandt ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 20042580
• Report Number: 3011468686-2024-00019
• Device Sequence Number: 7933764
• Product Code: BYS
• UDI-Device Identifier: 10854916006871
• UDI-Public: (01)10854916006871(17)241130(10)2210350
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K191935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/21/2024

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 Expiration Date: 11/30/2024
• Device Model Number: 48135
• Device Lot Number: 2210350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2022
• 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: Unknown