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

Model Number	CX-SE055
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Pressure Problem (3012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
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 kink in the 1/4-inch exit line from the oxygenator, accompanied by a decrease in partial pressure of oxygen (po2) values on the blood parameter monitor (bpm).The entire extracorporeal circuit, including the oxygenator, was replaced.The surgical procedure was completed successfully.There was a 45-minute delay of the procedure due to the change.There was no blood loss nor adverse consequences to the patient.
Event or Problem Description
Per clinical review: the complaint involved a tubing pack that was connected to a pediatric oxygenator that had a severe kink in the arterial tubing line exiting the arterial port of the oxygenator.This was discovered during initiation of bypass.Then the oxygenation performance of the oxygenator started to decrease, impacting the partial pressure of oxygen (po2) values to decline.Bypass was interrupted to change out the oxygenator and tubing pack with a complete new set.There was a delay.The surgery was successfully completed and there was no harm to the patient.The oxygenator and tubing pack were not returned to the manufacturer for further evaluation.A data log review was not shared with the manufacturer.Pictures were taken of the kinked tubing by the customer during bypass and shared with the manufacturer confirming the kinked tubing.
Additional Manufacturer Narrative
Updated blocks: b1, b2, b5 & h6.The reported complaint was confirmed.The user facility provided a picture of the issue which confirmed that the l18 tubing segment on line 1c was kinked.The most likely cause of the reported issue was determined to be due to a manual assembly error during the layering process.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: 23437866
• Report Number: 3017987980-2025-00022
• Device Sequence Number: 12917975
• Product Code: OEZ
• UDI-Device Identifier: 00699753525900
• UDI-Public: (01)00699753525900(17)270430(10)0001140826
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CX-SE055
• Device Lot Number: 0001140826
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown