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

Model Number	64556-03
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
During use of the device of the device for cardiopulmonary bypass (cpb), the connection of the 1/8-inch end of the tubing was not glued into the 1/4-inch piece of tubing causing it to leak.The surgical procedure was completed successfully.There were a few drops of blood loss during a pediatric case.There was no delay, nor adverse consequences to the patient.
Event or Problem Description
Per clinical review: this complaint involved a pediatric tubing pack that leaked blood during cardiopulmonary bypass around a 1/4 inch connector.The blood loss was minimal and there was no harm to the patient.The connector was not changed out.The complaint connector was not returned for investigation, but pictures were taken by the user and shared.
Additional Manufacturer Narrative
Corrected block: e1.Updated blocks: b5 & h6.The reported complaint was confirmed.Photo evidence was provided, and it was determined that the issue occurred on line 28 and 28a.The photo suggests that the tubing segments l17 and l15 of the affected lines were not properly bonded.The most likely root cause is a workmanship error in assembly at the time of executing the bonding connection where no or not enough solvent was added to the tubing-to-tubing interaction.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: 21607424
• Report Number: 3017987980-2025-00005
• Device Sequence Number: 9217281
• Product Code: OEZ
• UDI-Device Identifier: 00699753503496
• UDI-Public: (01)00699753503496(17)251130(10)0000629198
• 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): 10/30/2025

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: 11/30/2025
• Device Model Number: 64556-03
• Device Lot Number: 0000629198
• Was Device Available for Evaluation?: Yes
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 03/14/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2024
• 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
• Patient Sex: Unknown