MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NX19 OXYGENATOR W/4-LITER RESERVOIR; LEFT-SIDE OUTLET PORT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	3CX*NX19RW
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, they noticed an oxygenator failure.It is unknown if there was a delay, if the procedure was completed successfully and if there was a blood loss.Terumo continues to attempt to gain more information regarding this event from the user facility.As per user facility, there was oxygenator failure because the oxygenation has decreased even though the pressure was normal, no gas transfer for no apparent reason.Act 653 seconds.Oxygenator was exchange between 12:28 to 12:30 product was changed out.
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
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.
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, 67).The returned sample was inspected upon receipt and no anomalies were noted.It was then tested for its gas transfer performance.The unit was found to meet specification for its oxygen transfer and carbon dioxide removal.The unit was found to function as intended; therefore, a definitive root cause could not be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
Additional information was received from the clinical specialist states that, a partial pump record was shared, and this case was a repair of an aortic aneurysm.There was a 2-minute delay of oxygenation to the patient.The partial pressure of oxygen (po2) oxygenation value had dropped to a critical value of 85mmhg right before the oxygenator changeout.The activated clotting time (act) at that time was 653 seconds per the clinician, which is adequate.After the new oxygenator was inline and bypass was resumed, the po2 oxygenation value was an acceptable 421mmhg.The complaint oxygenator was functioning at the beginning of bypass, with first po2 value of 228mmhg with an unknown fraction inspired oxygen (fio2) setting.The po2 value gradually dropped until a critical value of 73mmhg was reached.Once the po2 value remained below acceptable levels at 85mmhg, the decision to change out the oxygenator was made.

• Brand Name: NX19 OXYGENATOR W/4-LITER RESERVOIR; LEFT-SIDE OUTLET PORT
• 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: 20269450
• Report Number: 1124841-2024-00102
• Device Sequence Number: 7212402
• Product Code: DTZ
• UDI-Device Identifier: 00699753450875
• UDI-Public: (01)00699753450875(17)250430(10)CF15
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K180950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/10/2025

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 Expiration Date: 04/30/2025
• Device Model Number: 3CX*NX19RW
• Device Catalogue Number: N/A
• Device Lot Number: CF15
• 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: 08/30/2024
• Supplement Date Received by Manufacturer: 10/08/2024; 12/17/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 11/01/2024; 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/18/2023
• 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
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 80 KG