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 Problems Injury (2348); Blood Loss (2597)

Event Date 03/04/2020

Event Type  malfunction  

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 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.

• 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
• Manufacturer (Section G): SAME
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 9918042
• MDR Text Key: 200833119
• Report Number: 1124841-2020-00080
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180950
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/16/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial