• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION STERILE FX25RWC W/ RES BLOOD GAS OXYGENATOR Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTERILE FX25RWC W/ RES
Type of DeviceBLOOD 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 Key9364973
MDR Text Key168223770
Report Number1124841-2019-00315
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151791
Number of Events Reported1
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 Received11/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2022
Device Model Number3CX*FX25RWC
Device Catalogue NumberN/A
Device Lot NumberXC04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received01/16/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/04/2019
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
-
-