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

Model Number	66388
Medical Device Problem Codes	Inaccurate Delivery (2339); Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the picture from the user facility, one of the lines was too long and appeared to have been switched with a different line which was too short.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the cardioplegia tubing pack was built backwards.Instead of being built 4:1, it was built 1:4 which was discovered mid procedure and could have caused too much cardioplegia to be delivered.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated block: h6.The reported issue was confirmed.The sample was not returned to the manufacturer for further evaluation.However, a photograph was provided, and it was identified that the issue occurred in line 18 of the drawing specification.The assembly was built with incorrect configuration of the cardioplegia.The tubing used for l2 and l12 tubing segments were swapped on line 18.The 1/8x1/16 tubing was used for the l2 tubing segment and 1/4x1/16 tubing was used for the l12 tubing.It was determined that this was a manual assembly issue reversing the cardioplegia ratio 4:1 to 1:4, resulting in an incorrect amount of cardioplegia being delivered to the patient.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 issue involved a tubing pack and a cardioplegia delivery circuit within it that had the wrong diameter tubing size in it.The tubing sizes were reversed.The issue 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 completed successfully.The cardioplegia circuit tubing was not returned to the manufacturer for further evaluation, however, pictures were taken and shared by the customer confirming the reported issue.Further investigation revealed that the 1/4-inch tubing was used where the 1/8-inch tubing should have been and vice versa.The cardioplegia tubing circuit was assembled in a 1:4 ratio instead of a 4:1 ratio.This was a workmanship error, with production associates not correctly using the specified diameter tubing, identified in the customers' specifications diagram.The result of this incorrect assembly is that the incorrect volume and concentration of cardioplegia was delivered to the patient since the customer was not aware of the tubing diameter change and did not change the flow constant factor on the roller pump.

• 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: 23662852
• Report Number: 3017987980-2025-00024
• Device Sequence Number: 21113129
• Product Code: OEZ
• UDI-Device Identifier: 00699753493261
• UDI-Public: (01)00699753493261(17)270331(10)0001266747
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/25/2026

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: 66388
• Device Lot Number: 0001266747
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/03/2025
• 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