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

Model Number 3CX*NX19RE

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2019

Event Type  malfunction  

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 Description

The user facility reported to terumo cardiovascular that after cardiopulmonary bypass, the oxygenator is leaking fluid gas at exhaust port.No patient involvement.

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.

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 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
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9467262
• MDR Text Key: 194318398
• Report Number: 1124841-2019-00331
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 00699753450868
• UDI-Public: (01)00699753450868
• Combination Product (y/n): N
• PMA/PMN Number: K180950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIVANOVA SMART COATED CIRCUIT.
• Patient Age: 42 YR
• Patient Weight: 121