MAUDE Adverse Event Report: Terumo Cardiovascular Systems Corporation Capiox FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.; Oxygenator, Cardiopulmonary Bypass

Model Number	3CX*FX25RWC
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has received the device for evaluation; however, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and when more information becomes available.For this reason, terumo references evaluation conclusion code 11.H3:  evaluation is in progress, but not yet concluded. .
Event or Problem Description
The user facility reported to terumo cardiovascular that prior to cardiopulmonary bypass, during prime, they noticed a rapid de-priming of the venous line after pump flow was stopped.*no patient involvement.*product was changed out.*procedure completed successfully.

• Brand Name: Capiox FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res.
• Common Device Name: Oxygenator, Cardiopulmonary Bypass
• Manufacturer (Section D): Terumo Cardiovascular Systems Corporation; 125 blue ball road; elkton MD 21921
• Manufacturer (Section G): Same
• Manufacturer Contact: douglas patton ; 125 blue ball road; elkton, MD 21921 ; +1(734)663-4145
• MDR Report Key: 50180577
• Report Number: 1124841-2026-00078
• Device Sequence Number: 9119763
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837(17)281130(10)5P22
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K151791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2026

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 Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: 5P22
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/29/2026
• 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: 07/15/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/22/2025
• 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