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	12/29/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, plasma leakage was observed.As per the user facility, the procedure was for a redo of aortic root replacement + emergent cabg (coronary artery bypass graft).The patient was given protamine after 14:34 bypass run.The pt decompensated with maps (mean arterial pressure) reaching as low as 25 while re-cannulating before going back on cpb (cardiopulmonary bypass) at 1500.The plasma leak first noticed at 1520.There was no blood loss due to leak; however, the patient did receive blood products secondary to outside factors of the plasma leak.The blood was sucked out of the nx 19 oxygenator.The product was not changed out; they did need to splice fx 15 oxygenator to the recirc line to adequately control the patients pco2 (partial pressure of carbon dioxide).*the delay was undetermined *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 january 22, 2024.  upon further investigation of the reported event, the following information is new and/or changed: d9 (device availability - added date returned to manufacturer); g3 (date received by manufacturer) ; g6 (indication that this is a follow-up report) ; h2 (follow-up due to additional information) ; h3 (evaluation is in progress, but not yet concluded, thus code 81).A second follow-up will be submitted upon completion of the investigation and/or submission of new information, thus tcvs references conclusions code 11.  all available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
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: 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 (updated device evaluated by manufacturer) ; h4 (device manufacture date); h6 (identification of evaluation codes 10, 3331, 4210, 19).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.

• 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: 18560070
• Report Number: 1124841-2024-00012
• Device Sequence Number: 17824095
• 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,Followup
• Report Date (Section B): 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• 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: 12/29/2023
• Supplement Date Received by Manufacturer: 01/24/2024; Not provided
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 02/13/2024; 04/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown