MAUDE Adverse Event Report: MC3, INC. VITALFLOW CONSOLE; BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE

Model Number	58100
Medical Device Problem Codes	Device Alarm System (1012); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Note: medical safety specialist reviewed the event information and concluded that there is no evidence to suggest that the patient¿s death was causally related to the device event involving the vitalflow console.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.
Event or Problem Description
It was reported that during use of the vitalflow console instrument, there was a significant increase in pressure differential (delta p) from 50 to 70, with a suspected clot in the pump head that was believed to have moved forward to the preoxy.An e10 alarm, which is a protective alarm that stops the flow, was triggered, resulting in flows stopping for approximately 15-20 seconds.A loud noise was heard coming from the motor, which resolved after the return of flow.The patient remained on the same amount of support after the event and had been on support for 41 days at the time.The patient subsequently died, with the death noted as presumably unrelated to the event.An attempt to retrieve data from the console was in progress at the time of the report.It was determined that the console and motor drive should be changed.No patient complications have been reported as a result of this event.Medtronic received additional information that when the case logs were reviewed, the customer noticed that there was an e60 onset alarm that appeared about a minute before the e10 onset and then it cleared after the e10 cleared.
Additional Manufacturer Narrative
Medtronic received additional information that the patient passed away approximately one week after the submission of this report due to acute hypoxic respiratory failure.The replacement pump used was a vitalflow centrifugal pump.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 CONSOLE
• Common Device Name: BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24399063
• Report Number: 3011468686-2026-00017
• Device Sequence Number: 8300095
• Product Code: QNR
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K250199
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/24/2026

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: 58100
• Device Catalogue Number: 58100
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: 03/13/2026; 06/03/2026
• Initial Report FDA Received Date: 02/20/2026
• Supplement Report FDA Received Date: 04/08/2026; 06/24/2026
• Date Device Manufactured: 07/31/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown