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
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 was for a tubing pack that involved a sampling manifold and the line coming off the sampling manifold where the male luer in the sampling line had broken off in the female port of the stopcock in that line.This occurred during cardiopulmonary bypass (cpb) and there was a blood loss of 10-20 milliliters (ml).The surgery was successfully completed and there was no harm to the patient and the line was replaced by the clinician.
Additional Manufacturer Narrative
The reported complaint was confirmed.During further investigation, it was noted that 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.Furthermore, the l0 tubing segment was 3 inches while the l1 tubing segment was 12 inches, which could also be seen as reversed in the photos provided.The most likely root cause of the reported issue was determined to be due to workmanship where a segment of line 1 was assembled in reverse.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: 18858873
• Report Number: 3017987980-2024-00009
• Device Sequence Number: 3325335
• 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
• 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: 02/14/2024
• Supplement Date Received by Manufacturer: 03/07/2024; 09/12/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 03/28/2024; 10/04/2024
• 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