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

Model Number	CX-FR248
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complaint was reported to the manufacturer on 20-nov-2024 and was initially deemed to be not reportable.Although there was no serious patient harm identified, additional information was received on 03-jan-2025 that there was an unknown amount of blood loss from the patient during a pediatric case and therefore this report is being submitted to the appropriate national competent authority.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the arterial tubing at the oxygenator outlet was not properly inserted and the clamp was not tight enough.There was an unknown amount of blood loss during the procedure on a pediatric patient.The surgery was completed successfully.There was no delay, nor adverse consequences to the patient.
Additional Manufacturer Narrative
The reported complaint was confirmed.Upon review of the provided photograph, it was noted that the tubing was not pushed past the second barb of the connection and was therefore not all the way on the connection.As a result, this could have caused improper placement of the tie band, causing it to be loose.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: this complaint from the user facility involved an oxygenator and tubing pack that had a blood leak develop at the arterial outlet port and tubing connection that was factory tie-banded.This occurred during cardiopulmonary bypass.There was a loss of blood from a slow drip, but the volume of blood loss was not objectively measurable per the reported information.The oxygenator was not changed out.There was no delay and the surgery was successfully completed.The oxygenator was not returned to the manufacturer for investigation.A picture was shared by the user.

• 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: 21106692
• Report Number: 3017987980-2025-00002
• Device Sequence Number: 20850003
• Product Code: OEZ
• UDI-Device Identifier: 00699753518414
• UDI-Public: (01)00699753518414(10)0000400375(17)250331
• Combination Product (Y/N): N
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2025

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: 03/31/2025
• Device Model Number: CX-FR248
• Device Lot Number: 0000400375
• 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: 01/03/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/28/2023
• 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