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	Obstruction of Flow (2423); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional info b5: medtronic received additional information that there was no leaks noted.The pump has been in use since 9 days.There was no visible damage to the pump, and no visible air.The anticoagulant heparin gtt started 2 days prior with goal ptt 40-50, ptt 39 5 hours prior to event.No visible clots in the circuit, scattered clots noted in the oxygenators (the patient had been running dual oxys for 2 days) device evaluation summary: the device was returned bloody with evidence of clotting around the impeller pivots.Visual inspection shows the impeller is loose inside the housing with evidence of damage to the upper pivot.The device was run on a bio console from 0-4000 rpm¿s, a noise level greater than 80 db was noted, the specification is less than 65 db.Reason for the return was confirmed.Additional info h6: updated the annex b and annex c codes additional info d9: device evaluated and the return date 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.
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 during use, the vitalflow tube set pump exhibited a grinding noise, pump failure, and the pump stopped.The device was replaced to complete the case. there was no adverse patient effect associated with this event.

• 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: 24660556
• Report Number: 9617601-2026-01944
• Device Sequence Number: 9243824
• Product Code: QWF
• UDI-Device Identifier: 10850007732339
• UDI-Public: (01)10850007732339(17)261010(10)230675079
• 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,Followup,Followup
• Report Date (Section B): 06/10/2026

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: 230675079
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2026
• Supplement Date Received by Manufacturer: 03/24/2026; 04/08/2026; 05/25/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 03/26/2026; 05/06/2026; 06/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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 Age: 27 YR
• Patient Sex: Male
• Patient Weight: 109 KG