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

Model Number	62974
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), there was a cardioplegia (cpg) blood leak.As a result, an alternate device was employed.The surgical procedure was completed successfully.There was approximately five milliliters (ml) of blood loss.There was no delay nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated block: h6.The reported complaint was confirmed.The most likely root cause of this issue can be attributed to workmanship error in the assembly process during the bonding of the connector and the tubing.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Event or Problem Description
Per clinical review: this complaint from the user facility involved a leak in the cardioplegia delivery tubing of the pack that was discovered during cardiopulmonary bypass (cpb).The tubing was changed out and there was no patient harm or delay.The device was not returned to the manufacturer for investigation.A picture was shared by the user.A possible cause for the leak would be that there was a lack of sufficient solvent at the connection of the tubing lines.This issue was likely due to workmanship involved in assembly of the line.A training was issued to production associated in regard to this event for awareness to operators involved in assembling the pack.

• 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 ; 7346634145
• MDR Report Key: 19949706
• Report Number: 3017987980-2024-00017
• Device Sequence Number: 8801589
• Product Code: OEZ
• UDI-Device Identifier: 00699753454880
• UDI-Public: (01)00699753454880(10)0000414911(17)250731
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 05/13/2025

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: 07/31/2025
• Device Model Number: 62974
• Device Lot Number: 0000414911
• 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: 07/17/2024
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 05/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2023
• 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