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

Model Number	74837-02
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the arterial line filtration (alf) purge line disconnected while on pump.The surgical procedure was completed successfully.There was a 200 milliliter (ml) blood loss.There was no delay nor adverse consequences to the patient.
Event or Problem Description
Per clinical review: this complaint involved a tubing pack that had a one-way valve disconnect in the tubing line that acts as a purge line to the arterial line filter.This occurred during cardiopulmonary bypass (cpb).There was a blood leak and blood loss of approximately 200 milliliters (ml).The tubing was not changed out.The surgery was successfully completed.A picture of the valve disconnect was provided.The valve and line were not returned to the manufacturer for investigation.
Additional Manufacturer Narrative
Updated block: h6.The reported issue was confirmed.During further investigation, the photos provided confirmed the reported issue.It shows that the valve was found on line 9, specifically between the one-way valve, and the l6 and l7 tubing, failing the requirement of the specification that states, each side of the one-way valve should be solvent bonded at line 9.The root cause is a workmanship error in assembly at the time of executing the bonding connection where not enough solvent or no solvent was added to the tubing-valve 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: douglas patton ; 6200 jackson road; ann arbor, MI 48103 ; 7346634145
• MDR Report Key: 18555005
• Report Number: 3017987980-2024-00002
• Device Sequence Number: 12694674
• Product Code: OEZ
• UDI-Device Identifier: 00699753494169
• UDI-Public: (01)00699753494169(10)0000426927(17)250430
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 10/01/2024

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: 04/30/2025
• Device Model Number: 74837-02
• Device Lot Number: 0000426927
• 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: 12/29/2023
• Supplement Date Received by Manufacturer: 02/24/2024; 09/06/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 03/18/2024; 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown