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); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 there was an alleged product issue with the vitalflow console instrument.During use, the vitalflow screen turned white while the pump continued spinning.The customer informed during a phone call that the mc3 logo flashed, and then the screen returned to normal.The alarm history was checked, confirming an e70 error.The instrument was used to complete the procedure.No impact to the patient was associated with this event.
Additional Manufacturer Narrative
Correction b5: medtronic received information that during use of a vital flow motor drive instrument, it was reported that the vitalflow screen turned white while the pump continued spinning.Mc3 logo flashed, and then the screen returned to normal.The alarm history was checked, confirming an e70 error (gui connection lost).The instrument was used to complete the procedure.There was no adverse patient effect associated with this event.Additional info b5: investigation at the contract manufacturer has identified the reported issue, a white screen followed by an e70 error (gui connection lost), was determined to be a software bug in the code that generates the alarm history screen which causes the screen to reset the first time the alarm history screen is viewed if a large number of alarms had been logged before viewing the screen.The instrument issue occurred during patient support.There was no adverse patient effect associated with this event.Additional investigation information, corrective and preventative actions will be documented in the medtronic corrective and preventative action plan (capa) track wise event that will be initiated.Dhr review is not required as there is an existing further action.The service history record was not reviewed as the information provided suggests no evidence of servicing issues with the device.There were no patient/clinical safety issues reported.Trends for issues with this product are reviewed at quarterly quality meetings.Unable to confirm customer complaint.Tested device for 30 minutes with no fault.Repair on the vitalflow device will not be performed per business agreement.No further action required 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: 23377213
• Report Number: 3011468686-2025-00098
• Device Sequence Number: 18358767
• Product Code: QNR
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K230364
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2026

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: 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: 09/29/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 02/23/2026
• Date Device Manufactured: 04/03/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3011468686-10/10/2025-00
• Patient Sequence Number: 1
• Patient Sex: Unknown