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

Model Number	77593
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the user facility, the team was not over tightening the part to cause the break.
Event or Problem Description
It was reported that during use of the device on extended life support, parts of the disposable snapped off when tightening.As mitigation, clamps were used on the circuit.The surgical procedure was completed successfully.There was a 100 cubic centimeter (cc) blood loss.There was no delay nor adverse consequences to the patient.
Additional Manufacturer Narrative
Updated block: b5.
Event or Problem Description
Per clinical review: this complaint involved a perfusion pack that had the male connector shear off from the manifold line during cardiopulmonary bypass when tightened.There was a blood loss of approximately 100 cubic centimeters (cc).There was no harm to the patient and the surgery was successfully completed.
Additional Manufacturer Narrative
The reported complaint was confirmed by the photo provided.As no part was returned for further evaluation, 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 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: 18495859
• Report Number: 1212122-2024-00002
• Device Sequence Number: 6991050
• Product Code: OEZ
• UDI-Device Identifier: 00699753514874
• UDI-Public: (01)00699753514874
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 06/18/2024

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: 01/31/2025
• Device Model Number: 77593
• Device Lot Number: 307113706
• 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: 12/19/2023
• Supplement Date Received by Manufacturer: 05/10/2024; 06/14/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 06/04/2024; 06/18/2024
• 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
• Patient Sex: Unknown