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	02/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024, after less than 1 hour use of a nautilus smart oxygenator, there was a decrease in flow and an increase in delta pressure.Reported as a clotting/flow issue.The patient had previously been on heparin therapy.The oxygenator was replaced with no further issues.The patient was reported as alive with no injury.
Additional Manufacturer Narrative
The device was returned for investigation.Investigation confirmed that there was no flow obstruction and no increased pressure.The biological residual observed on the returned device is consistent with numerous small clots within the blood that may have collected on the inlet side of the gas exchange bundle.Other than the inlet side, the fiber bundle is clear of blood residue.The cause of clotting is not established.There is no device issue found in relation to this occurrence.
Event or Problem Description
On 16-feb-2024, after less than 1 hour use of a nautilus smart oxygenator, there was a decrease in flow and an increase in delta pressure.Reported as a clotting/flow issue.The patient had previously been on heparin therapy.The oxygenator was replaced with no further issues.The patient was reported as alive with no injury.Additional information received on 21-mar-2024, through mdr mw5152343, indicated the oxygenator increased in delta pressure from the 20s to the 80s with a subsequent drop in systemic flows from the mid 3s to mid 2s, with increased revolutions per minute, flows were responsive.There was visible debris on the inlet side of the oxygenator, nothing noted on the outlet side.At 10am the oxygenator was changed with no complications.
Additional Manufacturer Narrative
The device was returned for investigation.Investigation confirmed that there was no flow obstruction and no increased pressure.The biological residual observed on the returned device is consistent with numerous small clots within the blood that may have collected on the inlet side of the gas exchange bundle.Other than the inlet side, the fiber bundle is clear of blood residue.The cause of clotting is not established.There is no device issue found in relation to this occurrence.

• 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: 18933550
• Report Number: 3011468686-2024-00007
• Device Sequence Number: 18464464
• Product Code: BYS
• UDI-Device Identifier: 10854916006871
• UDI-Public: (01)10854916006871(17)251130(10)2311224
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: 48135
• Device Lot Number: 2311224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2024
• Supplement Date Received by Manufacturer: 03/21/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown