• 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 CAPIOX RX25 OXYGENATOR EAST 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 CAPIOX RX25 OXYGENATOR EAST BLOOD GAS OXYGENATOR Back to Search Results
Model Number 3CX*RX25RE
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
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 they used to use the sx oxygenators, now they are using the rx oxygenators and have noticed the packaging is bigger on the rx, it takes up more space and is not good for the environment. There was no patient involvement.
 
Manufacturer Narrative
This follow-up report is submitted to fda in accord with applicable regulations ¿ and as indicated by terumo cardiovascular systems in the initial report submitted to the fda on may 27, 2016. (b)(4). A sample was not returned for evaluation and a lot number was not provided; therefore, a complete investigation could not be performed and the complaint is not confirmed. The packaging for rx products has not changed, this is not a functional issue with the product. 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 NameCAPIOX RX25 OXYGENATOR EAST
Type of DeviceBLOOD GAS OXYGENATOR
Manufacturer (Section D)
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
125 blue ball rd
elkton MD 21921
Manufacturer Contact
shari bailey
125 blue ball rd
elkton, MD 21921
8002837866
MDR Report Key5684711
MDR Text Key46072941
Report Number1124841-2016-00219
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130333
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number3CX*RX25RE
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Other Device ID Number(01)00699753450103
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-