• 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 SYSTEM CORP. STERILE FX25REC 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 SYSTEM CORP. STERILE FX25REC W/RES BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*FX25REC
Device Problem Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 10/10/2016
Event Type  malfunction  
Manufacturer Narrative
Terumo has received the actual device; however, the investigation has yet to be completed. Terumo plans on submitting a follow-up report when the investigation is complete and more information becomes available. (b)(4).
 
Event Description
The user facility reported to terumo cardiovascular that while the product was being removed from the box, there was a missing arterial temp port. No patient involvement as this occurred out of box.
 
Manufacturer Narrative
This follow-up report is submitted to the fda in accord with applicable regulations - and as indicated by terumo cardiovascular system in the initial report submitted to the fda on october 28, 2016. (b)(4). The returned sample was visually inspected and it was found to not have the thermistor in the oxygenator port as it should. There was also no evidence of chemical presence in the empty port. A retention sample from 3cx*fx25rwc lot uh11 was visually inspected and confirmed to have a thermistor properly bonded within the oxygenator port. Review of the product's device history record found that the specific serial number of the returned sample had passed final visual inspection, confirming that the thermistor had been present in the port at the time of packaging. It is likely that the thermistor had been inserted into the port of the oxygenator, but never dipped into the chemical to bond it into the port, allowing it to come loose and not be present at the time of use. All available information has been placed on file in quality management for appropriate tracking, trending and follow up.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTERILE FX25REC W/RES
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEM CORP.
125 blue ball road
elkton MD 21921
Manufacturer Contact
cathleen hargreaves
125 blue ball road
elkton, MD 21921
8002837866
MDR Report Key6064950
MDR Text Key58717616
Report Number1124841-2016-00368
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 health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/11/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2018
Device Model Number3CX*FX25REC
Device Catalogue NumberN/A
Device Lot NumberUH11
Other Device ID Number(01)00699753450820
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-