MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR

Model Number 3CX*FX25RWC

Device Problem Infusion or Flow Problem (2964)

Patient Problems Cardiac Arrest (1762); Injury (2348); Blood Loss (2597)

Event Date 10/30/2019

Event Type  Injury  

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 an inadequate oxygenation and co2 elimination. As per the user facility, at the beginning of the perfusion, the po2 level at the rear of the oxygenator was only 90mmhg, pco2> 50mmhg at 3. 3l gas flow and fio2 75%. In the course of the perfusion, fio2 and gas flow were further increased to 25 liters / fio2 100%. The po2 was between 67 and 102 mmhg, the pco2 between 43 and 55 mmhg. Approximately, after two hours of perfusion time an adequate oxygenation could not be maintained anymore, an additional oxygenator was integrated/connected in front of the defective oxygenator in the ecc (extracorporeal circulation) and there was a short cardiac arrest approximately for 100 seconds, due to the integration/connection. There was also a blood loss of less than 20 ml while cutting the tube. Afterwards, oxygenation and co2 elimination were adequate again. The product was not changed out. There was a delay for approximately 2 minutes. The procedure was completed successfully.

• Brand Name: STERILE FX25RWC W/ 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: 9364973
• MDR Text Key: 168223770
• Report Number: 1124841-2019-00315
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151791
• 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,Followup
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/31/2022
• Device Model Number: 3CX*FX25RWC
• Device Catalogue Number: N/A
• Device Lot Number: XC04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/22/2019 Patient Sequence Number: 1