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 Codes	Injury (2348); Blood Loss (2597)
Date of Event	03/04/2020
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 during cardiopulmonary bypass, there was plasma leakage at gas inlet and gas outlet side.Per user facility, the report documents the event and online data for a longer case with two sessions; first for approx.6.5h (including perfusion/reperfusion, etc) and second for approx.1.75h.In the second session, a plasma leakage was discovered and a second oxygenator was added after approx.0,25h perfusion time.The first session stopped @16:40 local time.The second session started @ 19:04 local time and stopped @ 20:47 local time; plasma leakage observed and 2nd oxy added.There is no act/heparin info documented since the last act value (@16:11).The plasma leakage was observed during the second session therefore it appears that the oxy was already in use (first session + standby) for approx.9h before the second session started.There was around 1 minute delay.There was less than 100ml blood loss + plasma leakage about 200ml.The product was changed out.The surgery 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 april 4, 2020.Upon further investigation of the reported event, the following information is new and/or changed: h6 (identification of evaluation codes 3331, 4101, 4114, 213, 67, 4315).Method code #1:3331 - analysis of production records.Method code #2: 4101 - testing of device from same lot/batch returned from user.Method code #3: 4114 - device not returned.Results code: 213 - no device problem found.Conclusions code #1: 67 - no problem detected.Conclusions code #2: 4315 - cause not established.The affected sample was not returned.However, a representative sample from the same lot was investigated for gas transfer performance per standard test method, built into a circuit with bovine blood conditioned to 37*c and hb of 12.7g/dl.The sample was determined to meet factory specifications and plasma leak was not noted during testing.It is noted that the oxygenator was used beyond the ifu recommended 6 hours.The oxygenator was used for 9 hours when the plasma leaking occurred.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: 9918042
• Report Number: 1124841-2020-00080
• Device Sequence Number: 2333652
• Product Code: DTZ
• UDI-Device Identifier: 00699753450868
• UDI-Public: (01)00699753450868
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2020

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: 08/31/2020
• Device Model Number: 3CX*NX19RE
• Device Catalogue Number: N/A
• Device Lot Number: XL16
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/09/2020
• Supplement Date Received by Manufacturer: 05/06/2020
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 05/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: STÖCKERT S5 - HLM 5
• Patient Age: 57 YR
• Patient Weight: 92