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

Model Number	75179
Medical Device Problem Codes	Device Misassembled During Manufacturing /Shipping (2912); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), during cardioplegia delivery, high potential hydrogen (ph) values were noticed, and the team was using a lot of fluid.The team inspected the tubing and realized it was 1/4-inch and 1/8-inch pump boot.It was supposed to be an 8:1 kit, but it was 4:1.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated blocks: b5 and h6.The reported complaint was not verifiable since the product was not returned for evaluation or testing.Multiple diligence attempts for part return were unsuccessful.Based on the complaint description, the wrong size tubing (1/4 and 1/8 inch) was used in the assembly, which created a blood cardioplegia ratio of 4 to 1 (4:1).The user's specifications state for an 8:1 blood cardioplegia ratio, with 17/64-inch and 3/32-inch tubing.Based on the description provided, the issue occurred on line 11 of the drawing specification.The assembly was reportedly built with incorrect configuration of the cardioplegia.After reviewing the drawing, there is no 1/8 tubing in the cardioplegia set, therefore based on the information provided, it is possible that an assembly was performed at incorrect locations and with the incorrect tubing sizes (1/8 and 1/4) within the cardioplegia set.A potential root cause is workmanship error, but with no photos or product returned to confirm the situation, the root cause is not verifiable.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: the team had an issue with their tubing pack and the cardioplegia delivery circuit within it that had the wrong diameter tubing sizes.This was discovered during cardiopulmonary bypass (cpb).The cardioplegia circuit tubing was not changed out.There was no harm to the patient, and the surgery was successfully completed.The result of this incorrect assembly is that the incorrect volume and concentration of cardioplegia was delivered to the patient.This occurred because the customer was not aware of the tubing diameter change and did not change and did not change the flow constant factor on the roller pump.The cardioplegia circuit tubing was not returned to the manufacturer for further investigation and no pictures were taken or shared by the user facility.

• 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: 22846343
• Report Number: 3017987980-2025-00011
• Device Sequence Number: 17230871
• Product Code: OEZ
• UDI-Device Identifier: 00699753500730
• UDI-Public: (01)00699753500730(10)0000954187(17)261031
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 03/19/2026

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: 75179
• Device Lot Number: 0000954187
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/03/2025
• 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