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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
Terumo has not received the device for evaluation; therefore, 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.
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator failed around 3.5 hours into bypass run.There was minimal to no gas transfer occurring.Product was not changed out.No blood loss.Procedure completed successfully.Patient expired.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on november 27, 2024.Upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned to manufacturer).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H3 (device evaluation anticipated - evaluation is in progress, but not yet concluded).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Additional Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations.Upon further investigation of the reported event, the following information is new and/or changed: b5 (added describe event or problem), g3 (date received by manufacturer), g6 (indication that this is a follow-up report), h2 (follow-up due to additional information and device evaluation), h3 (device evaluated by manufacturer), h6 (identification of evaluation codes 10, 3331, 213, 4315).Visual inspection was performed on the returned sample upon receipt, no anomalies such as a break in appearance was noted.However, during the decontamination process, the unit was noted to leak from the gas port.The sample was tested for the oxygen transfer and carbon dioxide removal performance in accordance with the product inspection protocol.It was confirmed that the actual sample met the factory's specifications.No anomalies were found.Based on the leak from the gas port, it was likely that a plasma leak occurred, hindering the contact between the blood and the gas.However, it was not possible to determine the cause of occurrence.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
Additional information obtained from the clinical specialist.A follow-up phone interview was conducted, and some details were shared with terumo.This patient was very sick and on extracorporeal membrane oxygenation (ecmo) bypass before the surgery.The surgery was a double lung transplant that was on cardiopulmonary bypass for nearly 7 hours with the fx25 oxygenator.The fx25 oxygenator is rated for 6 hours of use only.The patient crashed onto emergency bypass after the surgeon unexpectedly cut into a blood vessel.The first activated clotting time (act) value evaluating anti-coagulation was over 1000 seconds.During the period of the oxygenation performance issues, the act values were in the 600s seconds range.These values are adequate values during bypass in terms of heparinization, but do not reveal the blood concentration of heparin, as when a hepcon device is used, which would have given the clinician a more accurate assessment of anti-coagulation status.The oxygenation partial pressure of oxygen (po2) values during the performance issues were observed to be in the low 100s mmhg and then falling into the 60s mmhg.An additional oxygenator was inserted into the recirculation line of the perfusion circuit in attempt to improve oxygenation.The original oxygenator was not changed out.The oxygenation did improve, with po2 values rising into the 300s mmhg, before slowly falling again.The patient would not separate from cpb and was placed on ecmo bypass.The patient left the operating room to the intensive care unit (icu) on ecmo.The patient expired most likely after a terminal wean from ecmo bypass in the icu after an unknown amount of time.The perfusion stated that it was his opinion that the oxygenation issues of the fx25 oxygenator were not the cause of death of the patient in this complaint.

• 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 ; 7346634145
• MDR Report Key: 20800423
• Report Number: 1124841-2024-00125
• Device Sequence Number: 15201089
• Product Code: DTZ
• UDI-Device Identifier: 00699753450837
• UDI-Public: (01)00699753450837(17)270731(10)4K26
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K151791
• 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): 02/07/2025

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*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: 4K26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 12/05/2024; 01/16/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 12/23/2024; 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• 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 Age: 68 YR
• Patient Sex: Female