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

Model Number	48135
Medical Device Problem Code	Infusion or Flow Problem (2964)
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
On (b)(6) 2023, during use of a nautilus smart 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.
Additional Manufacturer Narrative
The device has been returned for analysis.The results are pending completion of the investigation.
Additional Manufacturer Narrative
The device has been returned for analysis.The water path restriction within the heat exchanger capillaries was confirmed.Increased water path restriction reduces the water flow rate supplied by the heater cooler device through the heat exchanger.
Event or Problem Description
On 22-aug-2023, during use of a nautilus smart 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.Additional information, received on 20-sep-2023, indicated the patient was on ecmo for about 12 hours prior to the reported event.

• Brand Name: MC3 NAUTILUS SMART ECMO OXYGENATOR
• Common Device Name: NAUTILUS SMART 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: martha rumford ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 17784635
• Report Number: 3011468686-2023-00016
• Device Sequence Number: 12276909
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2023

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 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: 08/22/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 09/20/2023
• Supplement Report FDA Received Date: 10/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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