MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE NX19RW W/4L RESERVOIR; BLOOD GAS OXYGENATOR

Model Number	3CX*NX19RW
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2024
Type of Reportable Event	Malfunction
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: 81 - evaluation is in progress, but not yet concluded.
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, the oxygenator was foamy.As per the user facility, the unit was noted to be frothy when cleaning up approximately 1 hour after bypass.The oxygenator has been primed for 9 hours at this point in time.There was no abnormality during bypass, and no negative effect on patient and issues that would contribute to the event.They were 288 minutes on pump, 2 pump runs, and 2 cross clamps.No protamine given between pump runs.Sweep fio2 was kept 80-100% during the procedure, 1-5-2.5 l/min.Clevidipine was used on bypass for an hour.No known consequence or impact to patient.The product was not changed out.Procedure was completed successfully.
Event or Problem Description
As per the clinical specialist: a plasma leak through the oxygenator bundle became evident within 30 minutes of blood flow circulation.The customer did share blood gas and anti-coagulation results.Upon review of the arterial blood gases, it is evident that oxygen and co2 removal gas exchange were acceptable during the bypass run for the patient with the complaint oxygenator.The review of the anti-coagulation data revealed adequate heparinization of the patient with the use of a hepcon device.Act values and heparin blood concentration levels were clinically acceptable with that of cardiopulmonary bypass.This bypass case consisted of 2 separate runs and 2 separate cross-clampings as a result of surgical technical issues with the surgery repair.No protamine was given from the time the end of the first run to the time of the beginning of the second run.The total time of the bypass case was 288 minutes or nearly 5 hours.
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 february 2, 2024.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 10, 3331, 4210, 4307).The unit was decontaminated upon receipt as per protocol.Bovine blood was circulated through the oxygenator at 4 lpm with approximately 250 mmhg of back pressure, and plasma leakage was noted within the first 30 minutes of circulation.It is possible that there are unknown factors that contributed to the plasma leakage.A definitive root cause was unable to be determined.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE NX19RW W/4L RESERVOIR
• 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: 18634725
• Report Number: 1124841-2024-00017
• Device Sequence Number: 18073819
• Product Code: DTZ
• UDI-Device Identifier: 00699753450875
• UDI-Public: (01)00699753450875
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2024

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: Health Professional
• Device Expiration Date: 07/31/2025
• Device Model Number: 3CX*NX19RW
• Device Catalogue Number: N/A
• Device Lot Number: CK14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• 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: 01/11/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2023
• 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