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	01/18/2024
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, foaming from the gas out port of the oxygenator was observed.As per the user facility, towards the end of the case (heart transplant), the sweep rates were increased noticeably (from 2 l/min to 4-4.5 l/min).A blood-tinged fluid in the oxygenator scavenging line was noticed.It was also noted it have blood-tinged foam around the "gas out" port.This was about 20-30 minutes prior to weaning from cpb (cardiopulmonary bypass).Gas transfer was still sufficient, and the patient was weaned successfully, as a mitigation.The patient was also receiving a liver transplant and the cardiac surgeon wanted to keep a bypass circuit at the surgical field as a precaution.The nx circuit was disposed of and replaced with an fx circuit.Additionally, the patient's condition is intubated, sedated, and stable.*no known consequence or impact to patient *the 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 march 12, 2024.Upon further investigation of the reported event, the following information is new and/or changed: b5 (added describe event or problem).D4 (additional device information - added exp date).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).H4 (device manufacture date).H6 (identification of evaluation codes 10, 3331, 4210, 4307).The affected sample was inspected upon receipt with no physical anomalies noted such as a break.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.
Event or Problem Description
Additional information from the clinical specialist states that, the oxygenator in this complaint was not changed out as the patient was 20 to 30 minutes from weaning from bypass.The pco2 values did rise in blood gas results and the clinician had to adjust the sweep rate from 2lpm to 4lpm to compensate for the decreased co2 removal performance as a result of the plasma leak.The oxygen transfer performance was deemed clinically acceptable.

• 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: 18694080
• Report Number: 1124841-2024-00025
• Device Sequence Number: 7205496
• Product Code: DTZ
• UDI-Device Identifier: 00699753450875
• UDI-Public: (01)00699753450875
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 04/04/2024

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: 08/31/2025
• Device Model Number: 3CX*NX19RW
• Device Catalogue Number: N/A
• Device Lot Number: CL11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2024
• 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: 01/20/2024
• Supplement Date Received by Manufacturer: 03/12/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2023
• 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 Age: 63 YR
• Patient Sex: Female