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

MAUDE Adverse Event Report: TERUMO 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 OXYGENATOR Back to Search Results
Model Number FX15
Device Problem Occlusion Within Device (1423)
Patient Problem No Information (3190)
Event Date 01/13/2016
Event Type  malfunction  
Event Description
Oxygenator was being used in cabg, when it was noted it was not working properly. After oxygenator was replaced there appeared to be fiber "clots" in the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameOXYGENATOR
Type of DeviceOXYGENATOR
Manufacturer (Section D)
TERUMO
MDR Report Key5393939
MDR Text Key36983102
Report NumberMW5059640
Device Sequence Number1
Product Code DTZ
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFX15
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/18/2016 Patient Sequence Number: 1
-
-