MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE NX19RE W/ 4L RES; BLOOD GAS OXYGENATOR

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	01/21/2021
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.Gas exchanger.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that during cardiopulmonary bypass, they noticed a plasma leak.As per user facility, the o2 started to go down they run their fio2 at 100% and keep their po2 values very high.The lowest po2 value on cpb was 493 mmhg.They were on cpb for 6.5 hours.No known impact or consequence to patient.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 february 26, 2021.Upon further investigation of the reported event, the following information is new and/or changed: d4 (additional device information - added expiration date) g3 (date received by manufacturer) g6 (indication that this is a follow-up report) h2 (follow-up due to additional information) h4 (device manufacture date) h6 (identification of evaluation codes 3331, 4114, 3221, 4315) type of investigation code #1: 3331 - analysis of production records type of investigation code #34: 4114 - device not returned results code: 3221 - no findings available conclusions code: 4315 - cause not established significant evaluation has been conducted to determine the potential cause of the reported events.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 is in progress to determine a root cause of this phenomenon.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: STERILE NX19RE W/ 4L RES
• Common Device Name: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 11388286
• Report Number: 1124841-2021-00032
• Device Sequence Number: 19874329
• Product Code: DTZ
• UDI-Device Identifier: 00699753450868
• UDI-Public: (01)00699753450868
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K180950
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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 Expiration Date: 11/30/2023
• Device Model Number: 3CX*NX19RE
• Device Catalogue Number: N/A
• Device Lot Number: YP14
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 02/26/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 88