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

Model Number	74921-02
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the tubing had an incorrect thickness.The 1/4-inch line in the cp set that goes in the roller pump with the 1/8 lines, instead of being 1/4 x 1/16 it was 1/4 x 1/32.The team believed the incompatibility caused a delivery issue of cardioplegia during cpb.As a result, an alternate pack was used.The surgical procedure was completed successfully.There was a 40-centimeter (cc) blood loss.There was no delay, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated block: d9.
Event or Problem Description
Per clinical review: this complaint involved tubing packs and the cardioplegia delivery tubing within it.The cardioplegia tubing kits were returned to the manufacturer for investigation.The first error was that one cardioplegia delivery tubing circuit had the incorrect tubing durometer in it.The cardioplegia circuit should have been one tubing with 1/4 x 1/16, 68 durometer mated with another tubing 1/8 x 1/16.The pack was discovered with tubing 1/4 x 1/16, 70 durometer mated with 1/8 x 1/16 tubing.Durometer of tubing is the softness of the tubing and typically will not affect the volume of cardioplegia delivered to the patient.It may have minimal affect to the clinicians' ability to load the tubing.The second error was that one cardioplegia delivery tubing circuit had the incorrect wall thickness in it.The cardioplegia circuit should have been one tubing with 1/4 x 1/16 thickness mated with another tubing 1/8 x 1/16 thickness.The pack was discovered with tubing 1/4 x 3/32 thickness mated with 1/8 x 1/16 thickness.The two varying thickness of tubing would most likely affect the required optimal occlusion setting of the roller pump.Both of these tubings are double loaded into a single roller pump that is used for cardioplegia delivery.With varying tubing thickness, the roller occlusions could be adjusted so that either the occlusion is tight, and may result in a roller pump jam, or that the occlusion is loose, resulting in blood backflow from the patient through the cardioplegia delivery needle if not closed.Either way, the inaccurate volume delivery of cardioplegia may occur to the patient.
Additional Manufacturer Narrative
Updated blocks: b5, h3 & h6 the reported complaint was confirmed.An evaluation of the tubing found that the 1/4 x 3/32 tubing was assembled on the l4 tubing segment instead of the required 1/4 x 1/16 tubing.The root cause of the issue was determined to be workmanship of a manual assembly error.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 30106 ; CS 30106
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 23409981
• Report Number: 3017987980-2025-00017
• Device Sequence Number: 18376549
• Product Code: OEZ
• UDI-Device Identifier: 00699753499188
• UDI-Public: (01)00699753499188(17)270531(10)0001160113
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/18/2026

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: 74921-02
• Device Lot Number: 0001160113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/03/2025; 02/12/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 11/25/2025; 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2025
• 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