MAUDE Adverse Event Report: MEDTRONIC MEXICO MEDTRONIC TUBING PACK; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	BB8B89R3
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Separation (1562); Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
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 during use of a custom tubing pack there was a leak.The sat/crit cuvette in the venous line seemed to not be solvent bonded.This resulted in a very small amount of air being entrained into the venous line.The customer simply secured the loose connection using a tie band and there were no further issues and the air entrainment stopped immediately.The leak originated from the tubing connection.The same leak did not appear in multiple packs.Patient blood loss did not occur because of the leak.An unplanned transfusion was not required.The device was used to complete the procedure.There was no adverse patient effect associated with this event.

• Brand Name: MEDTRONIC TUBING PACK
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21319965
• Report Number: 9612164-2025-00618
• Device Sequence Number: 20946738
• Product Code: DTZ
• UDI-Device Identifier: 00643169717985
• UDI-Public: 00643169717985
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/06/2025

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: 07/08/2026
• Device Model Number: BB8B89R3
• Device Catalogue Number: BB8B89R3
• Device Lot Number: 229885654
• 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: 02/05/2025
• Initial Report FDA Received Date: 02/06/2025
• Date Device Manufactured: 10/15/2024
• 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