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*FX15RW40C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2026
Type of Reportable Event	Death
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass there was an oxygenator failure while rewarming after circulatory arrest at 28 degrees celsius.As per the subsidiary, it resulted to prolonged hypoxia approximately 20 minutes.There was cerebral desaturation documented by near-infrared spectroscopy (nirs).There was a significant hemodynamic instability and worsening of the patient's condition intraoperatively and postoperatively.Actions were taken through emergency replacement of the oxygenator, massive blood transfusion, device was not retained for further investigation.The subsidiary also stated that blood loss was difficult to quantify.The oxygenator content was approximately 300 ml.The oxygenator change caused significant hemodilution, requiring massive transfusion (more so than substantial blood loss).
Additional Manufacturer Narrative
Terumo will not receive 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.

• 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: 50180446
• Report Number: 1124841-2026-00077
• Device Sequence Number: 13444488
• Product Code: DTZ
• UDI-Device Identifier: 00699753450790
• UDI-Public: (01)00699753450790(17)270630(10)4H08
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3CX*FX15RW40C
• Device Catalogue Number: N/A
• Device Lot Number: 4H08
• 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: 07/13/2026
• Initial Report FDA Received Date: 08/07/2026
• Date Device Manufactured: 07/12/2024
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown