MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV CUSTOM TUBING PACK; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number	HY11W65R1
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a custom tubing pack, it was reported that there was a minimal blood loss as a result of a blood leak, and there was no unplanned transfusion as a result of this leak.The leak occurred at line 4, vrv valve.The device was used to complete the procedure.There was no adverse patient effect associated with this event.
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
Additional information b5: medtronic received additional information that per the customer there was no noted air in the circuit or tubing.Correction b5: there was no additional adverse patient effect associated with this event.Correction d3 (mfr name), d3.6 (postal code).Additional codes img (annex g/component): these fields have been updated.Device evaluation summary: visual inspection showed no outward signs of any damage.The device had a test mark, which confirmed the vrv was tested prior to distribution.Functional testing of the returned device was performed at 0.5 l/min.The instructions for use provides an approximation for first time use of the negative and positive pressures required to open the umbrella relief valves at 0.5 l/min blood flow and these are approximately -205 mmhg and 318 mmhg.Our results indicated the negative pressure umbrella opened at -195 mmhg and the positive pressure umbrella valve opened at 358 mmhg verifying the functionality for the valves for the returned device.The acceptable function of the umbrella valves also confirms the duck bill valve functioned as intended.There was no leaking observed.The reason for return was not 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.

• Brand Name: CUSTOM TUBING PACK
• Common Device Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21889513
• Report Number: 9612164-2025-02019
• Device Sequence Number: 8273155
• Product Code: DWE
• UDI-Device Identifier: 00763000704841
• UDI-Public: 00763000704841
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 05/27/2025

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: 05/24/2026
• Device Model Number: HY11W65R1
• Device Catalogue Number: HY11W65R1
• Device Lot Number: 229210760
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 05/05/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 50 KG