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

Model Number	74808
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	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the pump boot was built using 1/8 inch inner diameter (id) and 1/4 inch id tubing instead 3/16 inch id and 3/32 inch id tubing.The perfusion team adjusted the dosage of the cardioplegia accordingly and finished the case.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Event or Problem Description
Per the clinical review: this complaint involved a tubing pack with a cardioplegia (cpg) tubing delivery set that allegedly had the wrong tubing diameter size in the roller pump tubing aspect of the circuit.The complaint is that the tubing was built 1/8 and 1/4 tubing instead of 3/16 and 3/32 tubing.This was discovered during cardiopulmonary bypass (cpb) after the second delivery of cpg.The circuit was not changed out.There was no harm to the patient.The cpg tubing set was not returned for investigation nor were any pictures taken to confirm the complaint.Upon reviewing the required tubing schematics for the account, it does reveal that the required tubing for the cpg roller pump was 1/8 and 1/4.
Additional Manufacturer Narrative
Updated block: b5.
Additional Manufacturer Narrative
Updated blocks: e1 and h6.The reported complaint was not verifiable since the product was not returned for evaluation or testing, nor were any photos provided for the reported issue.Multiple diligence attempts for part return were unsuccessful.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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 20864536
• Report Number: 3017987980-2024-00020
• Device Sequence Number: 8592282
• Product Code: OEZ
• UDI-Device Identifier: 00699753490499
• UDI-Public: (01)00699753490499(10)0000402230(17)250630
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/20/2025

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 Expiration Date: 06/30/2025
• Device Model Number: 74808
• Device Lot Number: 0000402230
• 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: 11/12/2024
• Supplement Date Received by Manufacturer: 06/13/2025; 07/31/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 07/07/2025; 08/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/03/2023
• 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