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

Model Number	48145
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation.The leak was confirmed.The leak was caused from surface damage to the outlet barb connector that consisted of a longitudinal scratch along the port from a sharp object or blade.The damage to the barb interrupted the circumferential seal with the pvc tubing causing the leak.Also observed was a mis-shaped port end which may have been due to tubing removal.The observed damage that resulted in the leak was not related to the manufacture of the device.
Event or Problem Description
On (b)(6) 2023, after less than 24 hours use of a nautilus oxygenator, the outlet had a leak and was dripping.The oxygenator was replaced with no impact to the patient.The patient was reported as alive with no injury.

• Brand Name: MC3 NAUTILUS ECMO OXYGENATOR
• Common Device Name: NAUTILUS 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: 18503752
• Report Number: 3011468686-2024-00002
• Device Sequence Number: 18093354
• Product Code: BYS
• UDI-Device Identifier: 10854916006901
• UDI-Public: (01)10854916006901(17)241231(10)2212151
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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

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: 12/31/2024
• Device Model Number: 48145
• Device Lot Number: 2212151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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
• Patient Sex: Unknown