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

Model Number	48135
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that during use of a nautilus smart extracorporeal membrane oxygenation, it was reported that air was observed in the arterial side top of the membrane on the second day of the procedure.It was during an interventional lung assist (ila) procedure.The lines were clamped, and the air was removed by drawing on the arterial port.The customer stated that the issue appeared to be micro bubbles slowly appearing in the arterial side.The air was drawn off for a second time and the issues went away for a few hours.However, the issue reappeared overnight.The patient was still on support; therefore, it was unclear if they were affected by the issue.The customer stated that the procedure of an interventional lung assist was not the typical use for the device, but it should not entrain air in any case.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
The device is expected to return for evaluation; investigation is ongoing to identify the reported issue.
Additional Manufacturer Narrative
The complaint device was tested.No device deficiency or malfunction identified.
Event or Problem Description
Medtronic received information that during use of a nautilus smart extracorporeal membrane oxygenation (ecmo) oxygenator, it was reported that air was observed in the arterial side on top of the membrane on the second day of the procedure.It was during an interventional lung assist (ila) procedure.The lines were clamped and the air was removed by drawing on the arterial port.The customer stated that the issue appeared to be micro bubbles slowly appearing in the arterial side.The air was drawn off for a second time and the issues went away for a few hours.However, the issue reappeared overnight. the patient was still on support, therefore, it was unclear if they were affected by the issue.The customer stated that the procedure of an interventional lung assist was not the typical use for the device but it should not entrain air in any case.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the root cause of air entry was not determined.There was no bubble detector used.The staff attempted to clear the bubbles by separating the patient from the circuit.They pushed the volume post oxygenator connector and aspirated at the top of the oxygenator.They cleared the air but it reaccumulated.Hours later, the customer aspirated the air out twice from the top of the post oxygenator pigtail without clamping off the circuit.Initially, it seemed effective.However, on night shift air began appearing on the post oxygenator membrane again.It required the circuit to be changed.The oxygenator was placed on an iv pole at or below patient level.There were times when the device was above patient level.The oxygenator level was not consistently at or above the level of the patient's heart as the patient was mobile and the device was being used as an ila.The yellow vent cap was always kept on for this reason.There was a stoppage in blood flow when the customer deaired the device quickly as stated above.There was no retrograde flow observed.Medtronic received additional information that the customer does not want to send the perfusion record due to privacy concerns around identifying the patient.

• Brand Name: MC3 NATUILUS SMART ECMO OXYGENATOR
• Common Device Name: NATUILUS SMART OXYGENATOR
• Manufacturer (Section D): MC3 INC.; 2555 bishop circle west; dexter MI 48130
• Manufacturer (Section G): MEDTRONIC DEXTER (MC3 INC.); 2555 bishop circle west; dexter MI 48130
• Manufacturer Contact: tanya pockrandt ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 19609650
• Report Number: 3011468686-2024-00017
• Device Sequence Number: 12392176
• Product Code: BYS
• UDI-Device Identifier: 10854916006871
• UDI-Public: (01)10854916006871(17)240930(10)2209267
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K191935
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 48135
• Device Lot Number: 2209267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown