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 Blood Loss (2597)

Event Date 10/28/2020

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, there was a plasma leakage. As per the sales associate, there was a negligible amount of blood loss and the customer resolve the issue by increasing the sweep to 2 to 4. As per the clinical specialist, the director of clinical specialist called the perfusionist on (b)(6) 2020. The perfusionist who started the case reported no issues during the hand off discussion. The plasma leak took place at the ending stages of the 5 hour and 13 minute procedure for a cabg x 4 aortic valve replacement procedure on a 72 y/o male. The perfusionist noted that this patient had been hospitalized 2 days prior to the surgery which is unusual, but he didn't know why. He didn't feel that the patient exhibited any inflammatory tendencies while on bypass although he did note that he needed to run his sweep gas higher than what he has experienced in the past, 3. 5 to 4 lpm versus 2lpm typically. It was not at all unmanageable and po2 was not affected at all, so during the conversation he concluded that it was most likely patient to patient variability. Another thing he noted was that the scavenge line on their boehringer vavd controller seemed to have more condensate than normal. But again, slower surgeon, potentially longer rewarm time. The patient was large - 102 kilos. They had to run a higher sweep than what they consider normal - 4 lpm versus typically running 2 lpm. Gas exchange performance was not a problem. There was a negligible amount of blood loss; the product was not changed out; procedure 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: jamie quinlan ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 10848834
• MDR Text Key: 216907918
• Report Number: 1124841-2020-00265
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/30/2020
• Device Model Number: 3CX*NX19RE
• Device Catalogue Number: N/A
• Device Lot Number: XP30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial