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

Model Number	75359
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), while delivering cardioplegia the perfusionist noticed that the solution color looked different than normal.It was found that the color-coded clamps were on the wrong lines causing the cardioplegia to blood ratio to not be what was expected.As mitigation, the other clamps were opened to rectify the issue.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated block: b5.
Event or Problem Description
Per clinical review: this complaint from the user facility involved a cardiovascular procedure kit and the cardioplegia delivery tubing circuit within it.Red colored and white colored plastic tubing clamps on specific segments of the tubing were reversed in location.The specification diagram revealed that the cardioplegia circuit has bypass shunts designed so as to deliver either a 4:1 conventional blood cardioplegia concentration or a 1:4 del nido cardioplegia concentration to the heart with the use of the colored clamps.The reversal of the location of the clamps and thus the wrong clamps being opened and closed resulted in the wrong cardioplegia concentration delivery being administered to the patient once the cross-clamp was applied on the aorta.The perfusionist noticed that the degree of red color of the cardioplegia concentration being delivered to the patient was incorrect.Inspection of the cardioplegia circuit by the perfusionist revealed that the red and white colored clamps that control the concentration of blood cardioplegia were reversed.The clinician rectified the situation by simply opening and closing the correct clamps to deliver the correct and intended concentration of cardioplegia.The circuit was not changed out by the perfusionist.
Additional Manufacturer Narrative
The reported complaint was confirmed by photographs provided by the user facility.The root cause of the reported issue was determined to be a workmanship error where the red and white clamps were placed in reverse.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: 18857485
• Report Number: 3017987980-2024-00006
• Device Sequence Number: 8240186
• Product Code: OEZ
• UDI-Device Identifier: 00699753507135
• UDI-Public: (01)00699753507135(10)0000412597(17)250430
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 03/07/2025

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: 04/30/2025
• Device Model Number: 75359
• Device Lot Number: 0000412597
• 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: 02/13/2024
• Supplement Date Received by Manufacturer: Not provided; 02/14/2025
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/19/2024; 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2023
• 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