MAUDE Adverse Event Report: Terumo Cardiovascular Costa Rica LLC Terumo Cardiovascular Procedure Kit; Cardiovascular Procedure Kit - Convenience Tubing pack

Model Number	CX-IE012X
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass, there was a leak at a y connector in cardioplegia pack within the neonate tubing pack.No other details regarding the nature of this event were provided.

• Brand Name: Terumo Cardiovascular Procedure Kit
• Common Device Name: Cardiovascular Procedure Kit - Convenience Tubing pack
• Manufacturer (Section D): Terumo Cardiovascular Costa Rica LLC; calle 58; cartago, zona franca la lima 30106 ; CS 30106
• Manufacturer (Section G): Same
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; +1(734)663-4145
• MDR Report Key: 50148098
• Report Number: 3017987980-2026-00009
• Device Sequence Number: 9341487
• Product Code: OEZ
• UDI-Device Identifier: 00699753535596
• UDI-Public: (01)00699753535596(17)271231(10)0001567254
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2026

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: CX-IE012X
• Device Lot Number: 0001567254
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2026
• 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