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

Model Number	75582-02
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	10/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the cardioplegia circuit was assembled backwards.It was meant to be a 1:4 circuit and it was built as a 4:1.The team had a difficult time arresting the patient's heart during surgery due to inadequate cardioplegia solution delivery.The unit was not changed out.The surgical procedure was completed successfully.There was no delay, no blood loss, nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated blocks: b5 and h6.The reported complaint was confirmed.Based on the photo evidence provided, the issues occurred in line 8 of the drawing specification.The assembly was built with incorrect tubing sizes connected to the y components, specifically in tubing l6 and l4.Tubing l6 was assembled with a 1/4 inch tubing instead of the required 1/8 inch tubing, and tubing l4 was assembled with a 1/8 inch tubing instead of the required 1/4 inch tubing.The root cause of the reported issue was a workmanship error as the pack was not assembled according to the specification.Line 8 of the cardioplegia set was assembled with an incorrect tubing size configuration, likely resulting from a mix-up between tubes l6 and l4.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 team experienced an issue with their tubing pack and the cardioplegia delivery circuit within it that had the wrong diameter tubing sizes in it.The tubing sizes were reversed.This 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 successfully completed.The result of this incorrect assembly was that the incorrect volume and concentration of cardioplegia was delivered to the patient.This occurred because the customer was not aware of the tubing diameter change and did not change the flow constant factor on the roller pump.Also, the customer was most likely using a delnido cardioplegia mixture, which is dictated to be delivered in a 1:4 ratio, that is 1 part blood to 4 parts crystalloid.The result was that the patient heart was difficult to arrest, as the improper concentration of blood cardioplegia was delivered.Thus, the patient was underdosed blood cardioplegia.The cardioplegia circuit tubing was not returned to the manufacturer for further investigation, however pictures were taken and shared by the customer.

• 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: 23639392
• Report Number: 3017987980-2025-00023
• Device Sequence Number: 15731298
• Product Code: OEZ
• UDI-Device Identifier: 00699753528697
• UDI-Public: (01)00699753528697(17)270831(10)0001266799
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 03/19/2026

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: 75582-02
• Device Lot Number: 0001266799
• 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: 02/26/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 03/19/2026
• 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