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 Known Impact Or Consequence To Patient (2692)

Event Date 10/30/2019

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 during cardiopulmonary bypass, the plasma was leaking out of the exhaust port.As per user facility, the patient is scheduled for bilateral orthotopic lung transplantation.They did not change out the product but they turned up the gas flow and turned off the fio2 setting.The patient has a body surface area (bsa) of 1.92m2, had 1200ml of plasmalyte, 600ml of blood and 250ml of colloid(alb).*no known impact or consequence to patient.*the surgery was completed successfully.

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 november 19, 2019.Upon further investigation of the reported event, the following information is new and/or changed: (identification of evaluation codes 10, 38, 3331, 4210, 4307).Method code #1: 11 testing of device from same lot/batch retained by manufacturer.Method code #2: 3331 analysis of production records.Method code #3: 4114 device not returned.Results code: 4210 leakage/seal.Conclusions code: 4315 cause not established.The affected sample was inspected upon receipt with fluid observed in the chamber, no other anomalies were noted.The affected sample was thoroughly rinsed and dried.The sample was setup for mechanical integrity testing, leakage was observed at 150mmhg of pressure.The unit was thoroughly dried again.Once dry, the unit was circulated with bovine blood at the pump record conditions (pressure, hematocrit, etc) with nitrogen flowing through the gas side.The unit leaked plasma shortly after starting circulation.The unit was then dyed with rhodamine and dissected.Analysis with a sem showed no anomalies.Ftir analysis showed protein remnants.The appropriate retention sample was tested for gas transfer ability at zero time and following a six hour blood circulation.Blood flow for testing and circulation was set to 8 l/min.The plasma leakage event was confirmed through provided pictures and through observation of the affected sample during a circulation of bovine blood.Significant evaluation was conducted to determine the potential cause of the reported event.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.Therefore, an exact cause of the plasma leakage could not be determined.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
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORPORATION; 125 blue ball road; elkton MD 21921
• MDR Report Key: 9343887
• MDR Text Key: 168837622
• Report Number: 1124841-2019-00312
• 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
• Report Date: 12/23/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 3CX*NX19RE
• Device Catalogue Number: N/A
• Device Lot Number: XH22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 12/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 75