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

Model Number	CX-SP162
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the device for cardiopulmonary bypass (cpb), the hemoconcentrator was found not to be sealed correctly, causing a leak at the connection.As a result, another hemoconcentrator from the same lot was employed but the same issue occurred.The hemoconcentrator was replaced again with one from a different lot and the issue was resolved.The surgical procedure was completed successfully.There was a delay of an unknown amount.There were approximately 200 milliliters (ml) of blood loss.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Per the user facility, the hemoconcentrator used to be 1/4 and sealed outside, and the lot they had was 3/16 and sealed on the inside but not sealed correctly.
Additional Manufacturer Narrative
Updated blocks: b5 and h6 the reported complaint was confirmed.During further investigation of the photo provided, the reported complaint was confirmed.The complaint information and evidence provided indicated that the issue occurred on line 1 of the drawing specification, where the incorrect type of tubing was used causing a leak between the connection of l3 and the connector 080189.The interaction between the connector 080189 and the 4.75x1.0 tubing was recreated to understand if this could have played a factor in the issue reported.The root cause of the reported issue was determined to be due to workmanship where the 4.75x1.0 tubing was used on the l1 or l3 instead of the specified 1/4x1/16 tubing, resulting in a leak.If additional information becomes available on this complaint that would alter the facts and/or conclusion, a supplemental report will be filed accordingly.
Event or Problem Description
Per clinical review: this complaint involved a tubing pack and the hemoconcentrator and tubing line connected to it, that leaked blood during cardiopulmonary bypass (cpb).The hemoconcentrator and tubing line was changed out with a new disposable from the same lot, and the leak re-occurred.New disposables from a different lot number were then used to perform another changeout and the issue resolved.The complaint disposables were not returned, but pictures and video were shared that confirmed the blood leak during cpb.There was approximately 200 cubic centimeter (cc) of blood loss to the patient, and the surgery was successfully completed.

• 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: 21374751
• Report Number: 3017987980-2025-00003
• Device Sequence Number: 19789905
• Product Code: OEZ
• UDI-Device Identifier: 00699753521704
• UDI-Public: (01)00699753521704(10)0000638613(17)260531
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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
• Report Date (Section B): 09/12/2025

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: 05/31/2026
• Device Model Number: CX-SP162
• Device Lot Number: 0000638613
• Was Device Available for Evaluation?: No
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/26/2024
• 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