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

Model Number	BB8B89R3
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows no outward signs of damage.Pressure integrity testing was performed at 0.5 l/pm with 23 psi, (1189 mmhg) of backpressure for 10 min.During the pressure integrity test there was a leak observed at one of the tubing "y" connections.Appears the leak is coming from the bond connection.Reason for return was confirmed.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 prior to use of a custom tubing pack, it was reported that there was a leak from the tubing connection.The same leak did not appear in multiple packs.The device was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the myotherm itself was not leaking.The leak came from the tubing connected to one of the wye connectors.The customer believed that the solvent may have been omitted from the tubing connection to the wye connector.
Additional Manufacturer Narrative
Correction b5: additional review of the event shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.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 prior to use of a custom tubing pack, it was reported that there was a leak from the tubing connection.The same leak did not appear in multiple packs.The device was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the myotherm itself was not leaking.The leak came from the tubing connected to one of the y connectors on the cardioplegia circuit.The customer believed that the solvent may have been omitted from the tubing connection to the y connector.

• 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: 19151300
• Report Number: 9612164-2024-01926
• Device Sequence Number: 18258860
• 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,Followup
• Report Date (Section B): 07/09/2024

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: 06/14/2025
• Device Model Number: BB8B89R3
• Device Catalogue Number: BB8B89R3
• Device Lot Number: 226998340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2023
• 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