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

Model Number	77450
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the user facility's director of perfusion, due to the manufacturer being out of the stock of the pack they routinely use, a substitute that the team was unfamiliar with was used, which is different from their pack as the oxygenator is pre-attached.Per the manufacturer's cardiac business manager, the issue occurred during a micro robotics case, which used a small incision and not a sternotomy.The case occurred in a dark room, which was necessary to perform the robotics surgery.A substitute pack which they had used approximately eight times prior was used.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the oxygen (o2) line was kinked.The team noticed that the blood looked dark in color, so they checked the gas flow by looking at a flow meter.Since the flow meter appeared to have flow, it was assumed the oxygenator was failing.The team decided they did not feel comfortable continuing the case and it was cancelled.There was no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated block: 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.The product sample was not returned for evaluation, and no photos were provided to support the reported issue.A potential root cause of the issue was determined to be due to a manual assembly error where the impacted line was incorrectly layered in the pack during assembly, resulting in a kink.However, no photo of the issue was provided, no sample was returned for further evaluation, and a review of manufacturing records revealed no related issues; therefore, the complaint could not be verified.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; 58 calle; 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: 22168784
• Report Number: 3017987980-2025-00007
• Device Sequence Number: 15755322
• Product Code: OEZ
• UDI-Device Identifier: 00699753513655
• UDI-Public: (01)00699753513655(10)0000820526(17)261130
• 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
• Report Date (Section B): 11/20/2025

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 Model Number: 77450
• Device Lot Number: 0000820526
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MECHANICAL FLOW METER.
• Patient Sex: Unknown