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

Model Number	75866
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), there was a leak in the arterial filter deaeration system during aortic clamping that resulted in a circulatory stoppage of two minutes and 30 seconds.Cpb was resumed without issue after repairing.At 35 minutes into cpb it was found that the three-way valve of the arterial filter broke.The valve was replaced and used for the remainder of the case.The surgical procedure was completed successfully.The patient received two unit of red blood cells.There were no adverse consequences to the patient.
Event or Problem Description
Per clinical review: this complaint involved a perfusion tubing pack that had a blood leak develop in the purge line coming off the external arterial filter during cardiopulmonary bypass (cpb).Cpb had to be stopped for two minutes 30 seconds to correct the leak.After this occurred, the three-way stopcock in this purge line broke.There was an undetermined loss of blood volume.The perfusionist did transfuse two units of red blood cells as a result of the blood loss.The circuit was not returned for investigation but a picture of the complaint circuit showing the tubing disconnect was provided.
Additional Manufacturer Narrative
Updated blocks: b1, b2, and b5.
Additional Manufacturer Narrative
The reported complaint was non-verifiable as no product was returned.Multiple diligence attempts for part return were unsuccessful therefore further evaluation and root cause analysis could not be performed.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: 18857843
• Report Number: 3017987980-2024-00007
• Device Sequence Number: 19664477
• Product Code: OEZ
• UDI-Device Identifier: 00699753501133
• UDI-Public: (01)00699753501133(10)0000359377(17)250331
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 09/13/2024

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: 03/31/2025
• Device Model Number: 75866
• Device Lot Number: 0000359377
• 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: 02/16/2024
• Supplement Date Received by Manufacturer: 05/09/2024; 09/13/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 05/31/2024; 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2023
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic