MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION TERUMO CARDIOVASCULAR PROCEDURE KIT; CARDIOVASCULAR PROCEDURE KIT - CONVENIENCE TUBING PACK

Model Number	73143-02
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for a cardiopulmonary bypass (cpb) procedure, the quest valve on the arterial vent line disconnected which caused an approximate 500 millimeter (ml) blood loss.The surgical procedure was completed successfully.There was no delay and no adverse consequences to the patient.
Additional Manufacturer Narrative
Additional information received from the user that at the time of the reported issue, the flow was around 3.5 liters per minute (l/min), and the pressure was at 60 mmhg positive pressure.Per supplier evaluation, there were no manufacturing or quality concerns identified during production of the lot.
Additional Manufacturer Narrative
Updated blocks: b1, b2, and b5.
Event or Problem Description
Per clinical review: the complaint involved a tubing pack that had a quest valve leak blood during cardiopulmonary bypass (cpb).The valve was changed out.There was approximately a 500 milliliter (ml) loss of blood.The surgery was successfully completed.The valve was not returned to the manufacturer for further investigation.The valve was in the aortic root vent line.
Additional Manufacturer Narrative
Updated block: d4, h6.The reported complaint was confirmed.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 SYSTEMS CORPORATION; 6200 jackson road; ann arbor MI 48103
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 18431947
• Report Number: 1212122-2024-00001
• Device Sequence Number: 6808521
• Product Code: OEZ
• UDI-Device Identifier: 00699753500143
• UDI-Public: (01)00699753500143(17)240831(10)313116806
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 04/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2024
• Device Model Number: 73143-02
• Device Lot Number: 313116606
• 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: 12/11/2023
• Supplement Date Received by Manufacturer: 02/23/2024; 04/01/2024; 03/31/2025
• Initial Report FDA Received Date: 01/02/2024
• Supplement Report FDA Received Date: 03/18/2024; 04/25/2024; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown