MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX15REC W/ 3L RES BLOOD GAS OXYGENATOR

Model Number 3CX*FX15RE30C

Device Problem Decrease in Pressure (1490)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2020

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, a great decrease in the performance of oxygenation occurred, due to a revision of the mitral prosthesis 90 minutes in cec. Additionally, it was necessary to increase almost to the maximum the gas exchange. They increased sweep gas flow to a higher flow as used to do during ecmo (extracorporeal membrane oxygenation) to remove the condesa. No known impact or consequence to patient. Product was not changed out. Procedure was completed successfully.

• Brand Name: STERILE FX15REC W/ 3L 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: 10501972
• MDR Text Key: 205931211
• Report Number: 1124841-2020-00213
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151389
• 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,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2021
• Device Model Number: 3CX*FX15RE30C
• Device Catalogue Number: N/A
• Device Lot Number: WM08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 11/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial