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

Model Number	BB10G09R2
Medical Device Problem Codes	Material Separation (1562); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
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 extracorporeal life support (ecls), there was a flow issue with the custom tubing pack.The pigtail used for continuous renal replacement therapy (crrt) was noted to be loose to secure and restrictive to flow.The perfusion, nursing and intensivist team pride themselves on crrt through vitalflow.The new stopcocks have impacted their events data and have also had an effect on a study they are working on.They requested another stopcock part (b)(6).They stated that these stopcocks are not performing like the stopcocks (b)(6) previously used in the pack.See attached.The device was replaced to complete the procedure.No patient complications have been reported as a result of this event.Medtronic received additional information that the patient required an iv line placed for crrt.

• 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: 21984554
• Report Number: 9612164-2025-02279
• Device Sequence Number: 12840219
• Product Code: DWE
• UDI-Device Identifier: 00763000995034
• UDI-Public: 00763000995034
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/08/2025

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 Model Number: BB10G09R2
• Device Catalogue Number: BB10G09R2
• Device Lot Number: 230517730
• 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: 04/11/2025
• Initial Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/23/2025
• 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