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	01/28/2024
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 after "cardiopulmonary" "bypass", the oxygenator was found with plasma leak.As per the user facility, this was discovered after bypass was discontinued; therefore, the product was not changed out, the case was finished successfully with very little blood loss, and there was no harm to the patient.
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 21, 2024.Upon further investigation of the reported event, the following information is new and/or changed: 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.Plasma leakage was noted within the first 30 minutes of circulation.The unit was circulated again with saline solution and sweeps were performed.Foaming was observed in the gas out cap.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: 18752083
• Report Number: 1124841-2024-00028
• Device Sequence Number: 19758796
• Product Code: DTZ
• UDI-Device Identifier: 00699753450875
• UDI-Public: (01)00699753450875
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/05/2024

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: 09/30/2025
• Device Model Number: 3CX*NX19RW
• Device Catalogue Number: N/A
• Device Lot Number: CM30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• 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: Not provided
• Supplement Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2023
• 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