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

Model Number	CX-SP171
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was blood leakage in the thermometer connection of the oxygenator.The leak was noticed during preparation, before going on pump.There was a blood leakage of a few milliliters (ml) and the user attempted to fix the issue by using additional cable ties but the issue remained, so the product was changed out.There was some delay due to changing out the product.There was a blood loss of a few ml during a pediatric case.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Updated blocks: b5 and h6 the reported complaint was confirmed.Per supplier evaluation, the component met all quality requirements and was in good condition upon leaving the supplier's facility.The manufacturer reviewed the design specifications and confirmed that the layering met the necessary integrity requirements.Additionally, all applicable assembly procedures were verified to ensure they provided clear instructions for proper assembly and handling.A review of the electronic device history record (edhr) found no evidence of rework, process deviations, raw material issues, or failures during production.The final release documentation confirmed that the product left the facility with no identified quality concerns.Further investigation into the manufacturer's manufacturing and distribution processes, as well as incoming inspection records, confirmed that the product was received, processed, and shipped under normal conditions.Since the affected unit was not returned for further evaluation, a definitive root cause could not be determined by the supplier.The most likely potential root cause of the reported issue was determined to be damage incurred during the shipping and handling of the device.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 with an fx05 oxygenator that had a leak develop at the thermowell connection.This occurred after prime but before cardiopulmonary bypass (cpb).The clinician attempted to mitigate the leak with tie bands but with no success.The tubing pack and oxygenator were changed out with new disposables.There was a delay but there was no harm to the patient.A picture of the oxygenator was provided by the user facility but the disposables were not returned to the manufacturer for investigation.

• 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: 19755779
• Report Number: 3017987980-2024-00015
• Device Sequence Number: 6623607
• Product Code: OEZ
• UDI-Device Identifier: 00699753526389
• UDI-Public: (01)00699753526389(10)0000498925(17)250531
• 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): 07/09/2025

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: 05/31/2025
• Device Model Number: CX-SP171
• Device Lot Number: 0000498925
• 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: 07/01/2024
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2024
• 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