MAUDE Adverse Event Report: MEDTRONIC MEXICO CUSTOM TUBING PACK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	11V45R
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of a custom tubing pack, the customer reported that the cardioplegia started leaking at the two connectors in the 1/4¿ blood line.Slow leaks were noticed from both connectors so perfusion had to tie band them.The device was used to complete the procedure.There was no patient impact associated with this event.Additional information received stated that the customer is unsure what point during the procedure the first leak occurred.Only a few drops of blood was lost due to the leak, and a transfusion was not required.There was no visible air in the system/tubing.

• Brand Name: CUSTOM TUBING PACK
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• 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: 13963517
• Report Number: 9612164-2022-01255
• Device Sequence Number: 4176906
• Product Code: DWF
• UDI-Device Identifier: 00763000637491
• UDI-Public: 00763000637491
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K171308
• 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 Assistant
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

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: 01/10/2024
• Device Model Number: 11V45R
• Device Catalogue Number: 11V45R
• Device Lot Number: 223578179
• 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: 03/04/2022
• Initial Report FDA Received Date: 03/31/2022
• Date Device Manufactured: 01/10/2022
• 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