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	Alteration in Body Temperature (4568)
Date of Event	08/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, ecmo was initiated on a patient.On (b)(6) 2023, after 3 days of use with a nautilus oxygenator, there was no heat transfer.The patient was maintaining a temperature of 32 degrees with the heater-cooler device set at 37 degrees.It was reported that an alarm occurred indicating, "temperature differential error.This error can be caused by blocked flow.Please check all connectors, hoses and valves in the water circuit".The tubing and heater-cooler device were replaced.The alarm continued and the heater-cooler was reprimed and reconnected.The patient's temperature was below 32 degrees and the circuit was changed out.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.

• 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: 17759145
• Report Number: 3011468686-2023-00015
• Device Sequence Number: 20499392
• 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
• Report Date (Section B): 09/15/2023

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 Model Number: 48135
• Device Lot Number: 2302190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 09/15/2023
• 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