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*FX25REC
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the pressure value (delta p) of oxygenator has increased.As per the user facility, at the beginning of the procedure, when the (heart lung machine) hlm was started, the activated clotting time (act) was over 500.After the hlm started up, the act dropped to 475.(b)(4) units of at were administered and (b)(4) units of heparin.The pressure in the oxygenator was significantly above the target value.Since there is then a risk that the oxygen will close, it was replaced.There was no significant blood loss.No significant delay to finish the procedure successfully.No consequence or health impact to patient product was changed out procedure was completed successfully.
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.
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 july 19, 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 (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: 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 of the actual sample was conducted upon receipt.There were no breakages found in its appearance.The actual sample was then rinsed and tested for pressure drop with bovine blood.The test confirmed that it met the factory's specifications, and no obstructions were found.Additionally, saline solution was flowed through the blood channel, and no formation of blood clots was observed.All available information has been placed on file in quality management for appropriate tracking, trending and follow-up.

• 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: 19785675
• Report Number: 1124841-2024-00084
• Device Sequence Number: 8269263
• Product Code: DTZ
• UDI-Device Identifier: 00699753450820
• UDI-Public: (01)00699753450820(17)260331(10)3E03
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2024

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: Other
• Device Expiration Date: 03/31/2026
• Device Model Number: 3CX*FX25REC
• Device Catalogue Number: N/A
• Device Lot Number: 3E03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2024
• Supplement Date Received by Manufacturer: 07/19/2024; 10/22/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 08/12/2024; 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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