• 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 controller, temperature, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass temperature controller.
Product CodeDWC
Regulation Number 870.4250
Device Class 2


Premarket Reviews
ManufacturerDecision
CINCINNATI SUB-ZERO PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GAMBRO
  SUBSTANTIALLY EQUIVALENT 2
JOSTRA
  SUBSTANTIALLY EQUIVALENT 2
MAQUET, INC.
  SUBSTANTIALLY EQUIVALENT 1
MINNTECH
  SUBSTANTIALLY EQUIVALENT 1
ORIGEN BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SEABROOK MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
SORIN
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Device operates differently than expected 191
Device displays error message 180
Insufficient heating 133
Bacterial contamination of device 128
Other (for use when an appropriate device code cannot be identified) 94
Insufficient cooling 81
Temperature issue 71
Leak 63
Device stops intermittently 48
Ambient noise issue 37
Electrical issue 35
Fluid leak 29
Device alarm system issue 27
Infusion or flow issue 21
No Information 20
Improper flow or infusion 19
Component missing 19
Fracture 18
No Known Device Problem 17
No flow 15
Failure to pump 13
Device inoperable 13
Torn material 13
Break 13
Failure to power-up 13
Overheating of device or device component 11
Noise, Audible 10
Mechanical issue 9
Connection issue 9
Power source issue 8
Incorrect or inadequate result 8
Pumping issue 8
Corrosion 7
Device Cleaning Issue 7
Material discolored 6
Smoking 6
Device Issue 6
Incorrect display 6
Crack 5
Calibration issue 5
Loose or intermittent connection 5
Impedance issue 5
Material Distortion 5
Contamination during use 5
Failure to sense 4
No display or display failure 4
Metal shedding debris 4
No code available 4
Biofilm coating in device 4
Device disinfection or sterilization issue 4
Naturally worn 4
Pumping stopped 4
Loss of power 4
Blockage within device or device component 4
Electrical shorting 3
Material deformation 3
Pressure issue 3
Failure to disinfect 3
Material torqued 3
Burn of device or device component 3
Erratic display 3
Material erosion 3
Restricted flowrate 3
Grounding malfunction 3
Circuit Failure 3
Use of Device Issue 3
Overfill 3
False alarm 3
Improper or incorrect procedure or method 3
Inaccurate flowrate 2
Misconnection 2
Device sensing issue 2
Electronic property issue 2
Improper device output 2
Material integrity issue 2
Failure to prime 2
Unknown (for use when the device problem is not known) 2
Material puncture 2
Difficult to open or close 2
Maintenance does not comply to manufacturers recommendations 2
Inappropriate or unexpected reset 2
Occlusion within device 2
Free or unrestricted flow 2
Failure to run on AC/DC 2
Low audible alarm 2
Failure to shut off 2
Misassembled by Users 2
Device clogged 2
Device emits odor 2
Hole in material 2
Foreign material present in device 2
Detachment of device component 1
Alarm not visible 1
Failure of device to self-test 1
Device maintenance issue 1
Peeled 1
Sensing intermittently 1
Dent in material 1
Reset issue 1
Air leak 1
Total Device Problems 1580

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 1 0 0 0 0 1 1 0 3 2
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 MAQUET Inc. II Jan-25-2007
2 Maquet Cardiovascular Us Sales, Llc II Jan-05-2016
3 Sorin Group USA, Inc. II Mar-17-2016
4 Sorin Group USA, Inc. II Jul-15-2015
5 Terumo Cardiovascular Systems Corporation II Jun-26-2015
6 Terumo Cardiovascular Systems Corporation II Feb-13-2015
7 Terumo Cardiovascular Systems Corporation II Jun-21-2013
8 Terumo Cardiovascular Systems Corporation II Nov-13-2012

-
-