MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION NX19 OXYGENATOR W/4-LITER RESERVOIR; RIGHT-SIDE OUTLET PORT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number	3CX*NX19RE
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, there was a plasma leakage.No health consequences or impact.Product was not changed out.Procedure completed successfully.
Additional Manufacturer Narrative
Terumo will not receive 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.
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 may 09, 2024.Upon further investigation of the reported event, the following information is new and/or changed: d1 (corrected brand name) d2a (corrected common device name) d4 (added expiration date & updated primary unique device identifier) h2 (follow-up due to correction and additional information) h4 (device manufacture date) 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: e1 (reporter name and address - corrected address line 1 and zip code).G3 (date received by manufacturer).G6 (indication that this is a follow-up report).H2 (follow-up due to correction and additional information).H6 (identification of evaluation codes 11, 3331, 4114, 3221, 4315).The affected sample was not returned for evaluation and photos were not provided; therefore, a thorough investigation could not be performed, and a root cause could not be determined.A representative retention sample from the same manufactured lot was obtained and tested.No foaming was observed during the test.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: NX19 OXYGENATOR W/4-LITER RESERVOIR; RIGHT-SIDE OUTLET PORT
• Common Device Name: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: 19281314
• Report Number: 1124841-2024-00054
• Device Sequence Number: 12342427
• Product Code: DTZ
• UDI-Device Identifier: 00699753450868
• UDI-Public: (01)00699753450868(17)260131(10)DC19
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2024

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: 01/31/2026
• Device Model Number: 3CX*NX19RE
• Device Catalogue Number: N/A
• Device Lot Number: DC19
• Was Device Available for Evaluation?: No
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 08/02/2024; 11/15/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 08/27/2024; 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2024
• 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