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

Model Number	HY12B71R2
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a cardiopulmonary bypass (cbp) procedure, the custom tubing pack and fusion oxygenator were associated with a flow issue characterized by low blood flow, high rpm, and low arterial line pressure post oxygenator between 9:05 am and 9:20 am.The patient was on cpb for 5 minutes when the flow issue occurred.The issue did not worsen over time.Heparin was used.Act (activated clotting time) values were in therapeutic range for cpb throughout the case.There was 1,500ml of isolyte solution used during priming.After this period of time, the blood flows began to increase to more normal values.The perfusion team changed out the centrifugal pump head when this first occurred but that did not seem to change the blood flows.The blood flows increased slowly over this 15 minute period, until they were back to normal blood flows.The blood flow was 3.68 l/min when cpb first started, at 9:05 a.M.It was down to 2.79 l/min, at 9:10 a.M., 2.9 lpm and at 9:15 a.M.And 4.0 lpm.At 9:20 a.M.The blood flow was up to 5.39 l/min and it remained between 5.5-6.0 l/min for the rest of the procedure.The customer indicated that they believed it was a high-pressure excursion event because the blood flows were low and the arterial line pressure post oxygenator was low.They do not monitor pre oxygenator pressures.The patient woke up as expected and they were in a sufficient condition post operative.The devices were used to complete the procedure.No patient complications have been reported as a result of this event.The fusion oxygenator lot numbers: associated with the pack are 230757620 and 230800319.
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: CUSTOM TUBING PACK
• 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: 22932393
• Report Number: 9617601-2025-01249
• Device Sequence Number: 13050627
• Product Code: DWF
• UDI-Device Identifier: 00763000941871
• UDI-Public: (01)00763000941871(17)261003(10)230883424
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K171979
• 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): 09/01/2025

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 Expiration Date: 10/03/2026
• Device Model Number: HY12B71R2
• Device Catalogue Number: HY12B71R2
• Device Lot Number: 230883424
• 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: 08/05/2025
• Initial Report FDA Received Date: 09/02/2025
• Date Device Manufactured: 03/28/2025
• 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