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

TPLC - Total Product Life Cycle

  • 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
 

New Search Back To Search Results
Device reservoir, blood, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass blood reservoir.
Product CodeDTN
Regulation Number 870.4400
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 5
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 11
COBE INC.
  SUBSTANTIALLY EQUIVALENT 9
DIDECO
  SUBSTANTIALLY EQUIVALENT 3
FRESENIUS
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 16
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 2
JOSTRA
  SUBSTANTIALLY EQUIVALENT 1
LIFESTREAM INT'L, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 7
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 11
MINNTECH
  SUBSTANTIALLY EQUIVALENT 2
PACE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
POLYSTAN
  SUBSTANTIALLY EQUIVALENT 1
SCIMED
  SUBSTANTIALLY EQUIVALENT 3
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 14
SORIN
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 10

Device Problems
Leak 24
Device damaged prior to use 18
Fluid leak 16
Other (for use when an appropriate device code cannot be identified) 16
Component(s), broken 13
Reservoir 12
Device Issue 8
Infusion or flow issue 7
Kinked 5
Detachment of device component 4
Device operates differently than expected 4
Device inoperable 4
Replace 4
Device displays error message 4
Hole in material 3
Disconnection 3
Crack 3
Break 2
Collapse 2
Restricted flowrate 2
Positioning Issue 2
Decrease in suction 2
Connection issue 2
No Known Device Problem 2
Electrical issue 2
Occlusion within device 2
Filter 2
Failure to pump 2
Suction issue 2
Filter break(s) 2
Performance 2
Device sensing issue 1
Electronic property issue 1
Material disintegration 1
Foreign material 1
Failure to prime 1
Difficult to remove 1
Obstruction within device 1
Increase in pressure 1
Insufficient heating 1
Optical distortion 1
Coagulation in device or device ingredient 1
Insufficient flow or underinfusion 1
Filtration issue 1
Temperature issue 1
Heat, failure to 1
Unsealed device packaging 1
Air leak 1
Material fragmentation 1
Device packaging compromised 1
Environmental Particulates 1
Blockage within device or device component 1
Pressure issue 1
Total Device Problems 198

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 1 1 0 0 0 0 0
Class III 0 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Circulatory Technology Inc II Apr-13-2010
2 Medtronic Perfusion Systems II Jul-24-2008
3 Medtronic Perfusion Systems III Jan-26-2008
4 Terumo Cardiovascular Corporation II Aug-04-2011

-
-