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

Model Number	CX-FR339
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Additional information was received that the surgical procedure was completed successfully.There was no blood loss nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated blocks: b5 and h6.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the valve on the aortic discharge suction line was not working.As mitigation, the valve was removed and a fitting was added to the line.There were no reported adverse consequences to the patient.No other details regarding the nature of this event were provided.
Additional Manufacturer Narrative
Please disregard the previous reports submitted related to this complaint.Additional information was received that the reported issue occurred during setup/during prime and therefore had no patient involvement and no reasonable potential to cause patient harm or a serious incident.

• 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: 18506707
• Report Number: 3017987980-2024-00001
• Device Sequence Number: 12750198
• Product Code: OEZ
• UDI-Device Identifier: 00699753518421
• UDI-Public: (01)00699753518421(10)0000389977(17)250331
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 03/14/2024

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-FR339
• Device Lot Number: 0000389977
• 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: 01/03/2024
• Supplement Date Received by Manufacturer: 01/17/2024; 02/19/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 02/09/2024; 03/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• 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