MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION CAPIOX FX15 OXY EAST WITH 3L RES STERILE; BLOOD GAS OXYGENATOR

Model Number	3CX*FX15RE30C
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The user facility reported to terumo cardiovascular that during to cardiopulmonary bypass, the oxygenator had poor gas transfer.As per the user facility, the case was for a coronary artery bypass grafting (cabg) x 5.The flow throughout the surgery remained around 4 to 4.5 liters per minute (l/min), with a sweep set at 3 lpm and the fraction of inspired oxygen (fio2) was kept at 100%.Sevoflurane was 2% throughout the surgery.The initial partial pressure of oxygen (po2) upon initiation was at 420.Arterial blood gasses (abgs) were performed every 30 minutes, with the next po2 at 159.8, followed by 94.8.The recirculation line was opened at this point and sighing of the oxygenator occurred every 10 minutes or less.The last po2 on pump before coming off was 138.4, and the patient's po2 after bypass was at 396.8.The unit was not changed out, as the anesthesiologist was notified of low po2 with and all other prothrombin (pt) values were within normal range.No known consequence or health impact to patient.Product was not changed out.Procedure was completed successfully.
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 june 18, 2024.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added exp date, updated udi information); g3 (date received by manufacturer) ; g4 (added pma/510(k) number); g6 (indication that this is a follow-up report) ; h2 (follow-up due to additional information) ; h4 (device manufacture date); h6 (identification of evaluation codes 3331, 4114, 3221, 4315).The affected sample was not returned for evaluation; therefore, a thorough investigation could not be performed, and a definitive root cause could not be determined.Review of the manufacturing record and the incoming inspection record of the involved product code/estimated lots found no anomaly in them.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX FX15 OXY EAST WITH 3L RES STERILE
• Common Device Name: BLOOD GAS OXYGENATOR
• 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: 19562526
• Report Number: 1124841-2024-00073
• Device Sequence Number: 12637834
• Product Code: DTZ
• UDI-Device Identifier: 00699753450806
• UDI-Public: (01)00699753450806(17)260930(10)3M16
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K151389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2024

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
• Device Expiration Date: 09/30/2026
• Device Model Number: 3CX*FX15RE30C
• Device Catalogue Number: N/A
• Device Lot Number: 3M16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 06/18/2024
• Supplement Report FDA Received Date: 07/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/19/2023
• 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