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

Model Number	48135
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a mc3 nautilus extra corporeal membrane oxygenator, it was reported that on initialization, the delta-p was reading low when the p-out pressure appeared higher than the p-in pressure.At that time, the venous oxygen saturation (svo2) and the arterial oxygen saturation (sao2) were as expected.The flip screen button was greyed out and would not work.Upon placing the device on the patient, it did appear normal with the play screen on startup/turning on.After about 15 minutes, the issue resolved and the p-in was higher than the p-out.The device was used to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that no error codes displayed.The device power was not cycled at the time of the issue.The customer attempted to power cycle the device before sending it back onto the battery.The device was previously off and it was primed for 2 weeks.The device was placed on the patient with the screen off.It was turned on and the play screen appeared and initialized as per normal.It immediately displayed a lo alarm for delta p.There was no liquid spilled on the device.The device was not near an rf emitter (hf surgical equipment, mri, diathermy, lithotripsy, electrocautery, rfid, electromagnetic anti- theft system, metal detector, etc.).It was kept in the hallway.The device was plugged in.It was unknown if the device was previously reporting the correct pressure values as it was previously off and not attached to patient.An accurate signal was noted immediately after the initialization screen.The circuit pressure was not determined using an alternate means.The correct path of blood flow, the color change in the tubing, arterial blood gases (abg) post oxygenator changed and an able to achieve previous flow rate with no observed issues to patient were means used to determine the inaccuracy.There was no change to the patient's status after the change out.Before the device change out, the device had a malfunctioned screen.There was no circuit pressures or temperature available.The flow was 4.7 lpm with rpm at 2965.Partial thromboplastin time (ptt) was 58 (1 hr before change out).The values normalized after 15-20 minutes.After the change out, the flow was 4.4lpm with rpm at 3260.The prothrombin time (pt) abg was recorded at 7.44, 47, 95 and 35.8 post-oxygenation.The abg was recorded at 7.47, 44, 407 and 32 and the ptt was 67 (6 hrs after changeout).

• 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: tanya pockrandt ; 2555 bishop circle west; dexter, MI 48130 ; 7349959089
• MDR Report Key: 20490340
• Report Number: 3011468686-2024-00025
• Device Sequence Number: 4106201
• Product Code: BYS
• UDI-Device Identifier: 10854916006871
• UDI-Public: (01)10854916006871(17)260531(10)2405320
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 10/20/2024

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: 05/31/2026
• Device Model Number: 48135
• Device Lot Number: 2405320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2024
• Initial Report FDA Received Date: 10/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/23/2024
• 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