MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR COSTA RICA LLC 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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: 81 - evaluation is in progress, but not yet concluded.
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the tubing broke at the manifold.As a mitigation, it was clamped and changed out.The surgical procedure was completed successfully.There was a delay in the procedure due to changing the tubing out.There was a blood loss of about 10 - 15 cubic centimeters (cc) during the pediatric case.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Updated block: b5.
Event or Problem Description
Per clinical review: this complaint involved a perfusion tubing pack that had a broken manifold sampling line in which the male adapter lure was broken from the tubing.This occurred during bypass and there was a 15 milliliter (ml) loss of blood.The manifold line was changed out.There was no harm to the patient and the surgery was completed successfully.
Additional Manufacturer Narrative
The reported complaint was confirmed.During further investigation, the 1/8 male connector connected to the l1 tubing segment and attached to the 4-way rotating stopcock was found to be broken off due to damage.In addition, the 1/8 male connector at the end of the l0 tubing segment was incorrectly assembled into the manifold connection where the 1/8 male connector at the opposite end of the line on the l1 tubing segment.This was noted by the orientation of the 4-way rotating stopcock being reversed in comparison to the specification requirements.The most likely root cause of the reported issue was determined to be damage due to workmanship during the production of this line.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: 18858403
• Report Number: 3017987980-2024-00008
• Device Sequence Number: 3325808
• Product Code: OEZ
• UDI-Device Identifier: 00699753514874
• UDI-Public: (01)00699753514874(10)0000362982(17)250430
• 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): 10/04/2024

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: 04/30/2025
• Device Model Number: 77593
• Device Lot Number: 0000362982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2024
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 05/10/2024; 09/12/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/04/2024; 10/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2023
• 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