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

Model Number	10A31R2
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed no outward signs of damage.Pressure integrity testing was performed at 0.5 l/min with 23 psi (1189 mmhg) of backpressure for 10 minutes.During the pressure integrity test there was a leak observed at one of the "y" connectors.The leaking connection was observed under magnification and there was evidence of a void in the bond.The 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.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, the customer reported a leak from the tubing connection.The customer stated the leak occurred at the flexible y connection.Patient blood loss was approximately 5cc.An unplanned blood transfusion was not required because of the blood loss from the leak.The same leak did not appear in multiple packs.The device was used to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the leak was from the tubing soft y connector.
Additional Manufacturer Narrative
Additional review of the event showed that the y connection was part of cardioplegia circuit, based on complaint history and risk analysis, the chance of a leak from a cardioplegia circuit resulting in a death or serious injury if this product event were to recur, in this device or a similar device, is remote.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 during use of a custom tubing pack, the customer reported a leak from the tubing connection.The customer stated the leak occurred at the flexible y connection.Patient blood loss was approximately 5cc.An unplanned blood transfusion was not required because of the blood loss from the leak.The same leak did not appear in multiple packs.The device was used to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that the leak was from the cardioplegia circuit tubing soft y connector.

• Brand Name: CUSTOM TUBING PACK
• Common Device Name: TUBING, PUMP, 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: 20756718
• Report Number: 9612164-2024-05490
• Device Sequence Number: 9264142
• Product Code: DWE
• UDI-Device Identifier: 00763000700515
• UDI-Public: 00763000700515
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/17/2025

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: 01/11/2026
• Device Model Number: 10A31R2
• Device Catalogue Number: 10A31R2
• Device Lot Number: 227891284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 11/22/2024
• Supplement Report FDA Received Date: 01/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/11/2024
• 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