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

Model Number	BB11W92R1
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a custom tubing pack, it was reported that a flow issue was experienced less than a minute into cpb (cardiopulmonary bypass).The patient had not previously been on heparin or another anti-coagulant therapy, and issue did not worsen over time.Heparin was used as an anti coagulant and was assessed using istat.The composition of solution used for priming was heparin and plasmalyte.The cpb (cardiopulmonary bypass) was initiated and optimal flows could not be achieved.The perfusionist added albumin and the situation corrected itself.Flows increased and the procedure resumed.The device was used to complete the procedure.There was no adverse patient effect associated with this event.On review of the product information, it was determined that the customer used this product after the use by date of 22-sep-2025.
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.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Correction b5: event description.Correction d2.Product code.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
Medtronic received information that during use of a custom tubing pack, it was reported that a flow issue was experienced less than a minute into cpb (cardiopulmonary bypass).The patient had not previously been on heparin or another anti-coagulant therapy, and issue did not worsen over time.Heparin was used as an anti coagulant, and was assessed using istat.The composition of solution used for priming was heparin and plasmalyte.The cpb (cardiopulmonary bypass) was initiated and optimal flows could not be achieved.The perfusionist added albumin and the situation corrected itself.Flows increased and the procedure resumed.The device was used to complete the procedure.There was no adverse patient effect associated with this event.On review of the product information, it was determined that the customer used this product after the use by date of 22-sep-2025.

• 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: 23815829
• Report Number: 9617601-2025-03502
• Device Sequence Number: 10092431
• Product Code: DWF
• UDI-Device Identifier: 00763000689148
• UDI-Public: (01)00763000689148(17)250922(10)227803096
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup
• Report Date (Section B): 03/11/2026

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 Expiration Date: 09/22/2025
• Device Model Number: BB11W92R1
• Device Catalogue Number: BB11W92R1
• Device Lot Number: 227803096
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/23/2023
• 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