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

Model Number	48135
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer reported the device was discarded.The root cause of the leak can not be determined without analysis of the device.
Event or Problem Description
On (b)(6) 2023, ecmo was initiated and a nautilus smart oxygenator began leaking blood from the gas exhaust port.The oxygenator continued to flow and oxygenate.Within 30 minutes the oxygenator was changed out.It was estimated that the oxygenator leaked approximately 60 to 100ml of blood.

• Brand Name: MC3 SMART NAUTILUS ECMO OXYGENATOR
• Common Device Name: NAUTILUSOXYGENATOR
• 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: 17552544
• Report Number: 3011468686-2023-00013
• Device Sequence Number: 15127105
• Product Code: BYS
• UDI-Device Identifier: 10854916006871
• UDI-Public: (01)10854916006871(17)241130(10)2211197
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 08/15/2023

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 Catalogue Number: 48135
• Device Lot Number: 2211197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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