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); Communication or Transmission Problem (2896); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information that during use of a vital flow set, it was reported that at initiation, the circuit was presented with e49 error code and an intermittent/unreliable pressure and saturation readings.After 4 days of support without patient support issues, the circuit suddenly went to zero flow with a loud rattling sounds emanated from the pump head.Pump was transitioned to hand crank and back to motor, and was able to achieve flow with loud rattle persisting.Pump went to zero flow once more and then a decision was made to perform an urgent circuit exchange.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.
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.

• 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 ; +353(091)708096
• MDR Report Key: 50097281
• Report Number: 9617601-2026-04845
• Device Sequence Number: 10479615
• Product Code: DWF
• UDI-Device Identifier: 10850007732339
• UDI-Public: (01)10850007732339(17)270912(10)233807650
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 07/31/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 58112
• Device Catalogue Number: 58112
• Device Lot Number: 233807650
• 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: 07/21/2026
• Initial Report FDA Received Date: 07/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/15/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown