• 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 FX15REC W/ 4L 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 FX15REC W/ 4L RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX15RE40C
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
The user facility reported to terumo cardiovascular group that during cardiopulmonary bypass, there was not adequate membrane oxygenation with parameters that evidence to a low po2 in extracorporeal circulation with a flow rate between limit. Many changes in fio2, and arterial flow to support the low oxygenation. The location of the hospital has an atmospheric pressure of 560 mmhg and an altitude of 2640 meters over sea level. The perfusionist believes that the low oxygen delivery is due to the atmospheric pressure and high level city. No consequence or impact to the patient. Product was not changed out. Procedure was completed successfully.
 
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).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTERILE FX15REC W/ 4L 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
jamie quinlan
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key14338453
MDR Text Key291391858
Report Number1124841-2022-00103
Device Sequence Number1
Product Code DTZ
UDI-Device Identifier00699753450813
UDI-Public(01)00699753450813
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 Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3CX*FX15RE40C
Device Catalogue NumberN/A
Device Lot NumberZG21
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/13/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-