MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR COSTA RICA LLC TERUMO CARDIOVASCULAR PROCEDURE KIT; CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK

Model Number	74799-02
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the small adult pack had a leaking cardioplegia set and a bonding issue at the y connector.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was no delay, nor adverse consequences to the patient.There was an unknown amount of blood loss.
Additional Manufacturer Narrative
Updated block: e1.
Event or Problem Description
Per clinical review: this complaint involved a cardioplegia tubing kit that leaked blood at a y connector during cardiopulmonary bypass (cpb).An unknown amount of blood was lost.The cardioplegia tubing kit was changed out with a new kit.The surgery was successful and there was no harm to the patient.The kit was not returned for further evaluation.
Additional Manufacturer Narrative
Updated blocks: b5 and h6.The reported complaint was confirmed based on other complaints within this pack related to the same issue.The most likely root cause of the reported issue was determined to be due to workmanship while executing the bonded connection of the y-connector on the line where too little solvent was applied, resulting in a leak.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.

• 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 21402642
• Report Number: 3017987980-2025-00004
• Device Sequence Number: 20912120
• Product Code: OEZ
• UDI-Device Identifier: 00699753528680
• UDI-Public: (01)00699753528680(10)0000684356(17)260731
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/27/2025

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: 07/31/2026
• Device Model Number: 74799-02
• Device Lot Number: 0000684356
• Was Device Available for Evaluation?: Yes
• 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: 01/24/2025
• Supplement Date Received by Manufacturer: 05/12/2025; 08/06/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 06/02/2025; 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2024
• 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