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 Patient Involvement (2645)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Terumo has received 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.(b)(4).
Event or Problem Description
The user facility reported to terumo cardiovascular that after cardiopulmonary bypass, the oxygenator is leaking fluid gas at exhaust port.No patient involvement.
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 december 13, 2019.Upon further investigation of the reported event, the following information is new and/or changed: (identification of evaluation codes 10, 11, 3331, 213, 4315)/ method code #1: 10: testing of actual/suspected device.Method code #2: 11: testing of device from same lot/batch retained by manufacturer.Method code #3: 3331 analysis of production records.Results code: 213 no device problem found.Conclusions code: 4315 cause not established.The affected sample was inspected upon receipt with no anomalies noted.The unit was thoroughly dried following decontamination.After drying, the unit was pressurized per the mechanical integrity test.The unit leaked at approximately 300mmhg.The unit was thoroughly dried again.Once dry, the unit was circulated with bovine blood with nitrogen flowing through the gas side.The plasma leakage event was confirmed through provided pictures.The unit was subjected to circulation testing with no anomaly noted.The retention unit was subjected to gas transfer testing before and after a six hour circulation period.With no significant observations made, it's possible that patient/clinical conditions may have contributed to the issue.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: a2 (added patient age) a3 (added patient sex) a4 (added patient weight) b5 (added description of event) b7 (added other relevant history and preexisting medical conditions d11 (added concomitant medical products) g4 (date received by manufacturer) g7 (indication that this is a follow-up report) h2 (follow-up due to additional information).All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.
Event or Problem Description
Additional information was received indicating that the patient was in for aortic valve replacement (avr), septal myectomy and maze procedure.The patient was cooled to 28 degree celsious during first pump run and co2 flush in pericardium for open procedures.They were on and off cpb three times with approximately 280 minutes of total pump run.Per user facility the third time back on cpb was for bleeding control due to prolene deficiency.The issue was noted after 3rd pump run.

• 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: 9467262
• Report Number: 1124841-2019-00331
• Device Sequence Number: 14452878
• Product Code: DTZ
• UDI-Device Identifier: 00699753450868
• UDI-Public: (01)00699753450868
• 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
• 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): 01/15/2020

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: 07/31/2020
• Device Model Number: 3CX*NX19RE
• Device Catalogue Number: N/A
• Device Lot Number: XK19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 12/18/2019; 01/13/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 12/23/2019; 01/15/2020
• 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: LIVANOVA SMART COATED CIRCUIT.
• Patient Age: 42 YR
• Patient Weight: 121