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 Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2021
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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that there was a plasma leakage.It is unknown when this event occurred, whether the product was changed out, or if there was any effect on the patient or results of the surgery.Terumo continues to attempt to gain more information regarding this event from the user facility.
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 september 3, 2021.  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.
Event or Problem Description
Additional information received indicates that, the event occurred during cardiopulmonary bypass, there was no delay in the procedure, the product was not changed out and the surgery was completed successfully with 5-10 cc of blood loss.In order to mitigate or resolve the problem, they mopped up the foam in the floor.
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: g6 (indication that this is a follow-up report).H2 (follow-up due to additional information).H6 (identification of evaluation codes 4114, 4210, 4315).Type of investigation: 4114 - device not returned.Investigation findings: 4210 - leakage/seal.Investigation conclusions: 4315 - cause not established.Significant evaluation has been conducted to determine the potential cause of the reported events and there has been multiple laboratory tests and evaluations.An exact cause of the plasma leakage could not be determined at this time.An engineering investigation and a capa have been initiated and is currently working to determine a root cause.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
• MDR Report Key: 12424556
• Report Number: 1124841-2021-00211
• Device Sequence Number: 4633910
• Product Code: DTZ
• UDI-Device Identifier: 00699753450875
• UDI-Public: (01)00699753450875
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/20/2021

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 Model Number: 3CX*NX19RW
• Device Catalogue Number: N/A
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/19/2021
• Supplement Date Received by Manufacturer: 09/13/2021; 10/18/2021
• Initial Report FDA Received Date: 09/03/2021
• Supplement Report FDA Received Date: 09/30/2021; 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1