MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV VITALFLOW SET; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	58112
Medical Device Problem Codes	Device Alarm System (1012); Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the mc3 vital flow nautilus extracorporeal membrane oxygenation (ecmo) oxygenator experienced an unresolvable oxygenator failure, with errors e47 (oxy communication lost) and e49 (oxy error - outlet board) occurring while the device was running in prime mode prior to patient use.The e47 error was observed on a new circuit after the device initially functioned appropriately, occurring approximately 12 hours after priming, and was preceded by the e49 error.They leave their primed backup consoles running in prime mode in order for a specialist to do circuit checks during shift.They quickly ruled out both cable and console as the source and focused on the oxygenator itself.They were stored in a locked pump room.Moisture droplets were observed in the outlet sensor housing, and fluid was observed leaking from the bottom of the device when it was removed from the mounting bracket.No heater c ooler water hoses had been connected, indicating the fluid originated from priming.Although no visible external damage or cracks were seen, moisture was evident in the arterial sensor housing, suggesting a possible crack, break, or hole at that location.A complete crack/break did not occur.The device was replaced.No patient complications have been reported as a result of this event.The serial number of the oxygenator was 481065559.Medtronic received additional information that the device was plugged in, power on, and primed waiting to be used on a patient, but not put on a patient due to the moisture observed in the arterial monitoring casing.The device started with error code 47 then switched to error code 49.There were no events leading up to the display of the error code, the unit was waiting to be used.The smart ecmo module was not subjected to a liquid spill.The smart ecmo module was not near an rf emitter.The device was plugged in.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows evidence of moisture ingress inside the qb-outlet port electronic sensor area.Unit appears to have been primed.The device was connected to a vitalflow console, and it displayed error code 47 and then 48.Error code 47 has to do with lost communication and error code e49 has to do with the outlet port board.Pressure integrity testing was performed at 3 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there was a leak observed under the qb-outlet circuit board.Reason for the return was confirmed.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information h6.4 eval code conclusion (fdc/annex d): this field was updated.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: VITALFLOW SET
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23666010
• Report Number: 9617601-2025-03068
• Device Sequence Number: 18370268
• Product Code: DWF
• UDI-Device Identifier: 10850007732339
• UDI-Public: (01)10850007732339(17)261010(10)232113888
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K240880
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 58112
• Device Catalogue Number: 58112
• Device Lot Number: 232113888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2025
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 11/27/2025
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2025
• 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