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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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
Bacterial contamination of device 260
Device displays error message 223
Device operates differently than expected 193
Insufficient heating 139
Other (for use when an appropriate device code cannot be identified) 94
Insufficient cooling 82
Temperature issue 73
Leak 63
No Known Device Problem 53
Device stops intermittently 48
Electrical issue 37
Ambient noise issue 37
Fluid leak 31
Device alarm system issue 28
No Information 27
Infusion or flow issue 21
Improper flow or infusion 19
Component missing 19
Fracture 18
No flow 15
Failure to pump 14
Failure to power-up 13
Device inoperable 13
Break 13
Torn material 13
Overheating of device or device component 11
Mechanical issue 10
Biofilm coating in device 10
Noise, Audible 10
Pumping issue 9
Connection issue 9
Power source issue 8
Corrosion 8
Contamination during use 8
Incorrect or inadequate result 8
Device Cleaning Issue 7
Device Issue 7
Smoking 6
Blockage within device or device component 6
Material discolored 6
Incorrect display 6
Loose or intermittent connection 5
Pumping stopped 5
Crack 5
Burn of device or device component 5
Calibration issue 5
Foreign material present in device 5
Impedance issue 5
Material Distortion 5
No code available 5
Naturally worn 4
Device disinfection or sterilization issue 4
Failure to sense 4
Metal shedding debris 4
No display or display failure 4
Loss of power 4
Use of Device Issue 3
Grounding malfunction 3
Circuit Failure 3
Material erosion 3
Restricted flowrate 3
Failure to disinfect 3
Erratic display 3
False alarm 3
Improper or incorrect procedure or method 3
Overfill 3
Electrical shorting 3
Electronic property issue 3
Material torqued 3
Pressure issue 3
Material deformation 3
Sediment, precipitate or deposit in device or device ingredient 3
Device handling issue 2
Misassembled by Users 2
Failure to shut off 2
Material integrity issue 2
Inappropriate or unexpected reset 2
Maintenance does not comply to manufacturers recommendations 2
Device sensing issue 2
Difficult to open or close 2
Improper device output 2
Free or unrestricted flow 2
Obstruction within device 2
Unknown (for use when the device problem is not known) 2
Low audible alarm 2
Failure to run on AC/DC 2
Calcified 2
Device clogged 2
Inaccurate flowrate 2
Hole in material 2
Misconnection 2
Occlusion within device 2
Device emits odor 2
Failure to prime 2
No device output 2
Material puncture 2
Unable to obtain readings 1
Increase in pressure 1
Decreased pump speed 1
Increased pump speed 1
Total Device Problems 1844

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 1 0 0 0 0 1 1 0 3 5 0
Class III 0 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 Nov-03-2016
3 Maquet Cardiovascular Us Sales, Llc II Jan-05-2016
4 Sorin Group USA, Inc. II Dec-01-2016
5 Sorin Group USA, Inc. II Mar-17-2016
6 Sorin Group USA, Inc. II Jul-15-2015
7 Terumo Cardiovascular Systems Corporation II Jul-14-2016
8 Terumo Cardiovascular Systems Corporation II Jun-26-2015
9 Terumo Cardiovascular Systems Corporation II Feb-13-2015
10 Terumo Cardiovascular Systems Corporation II Jun-21-2013
11 Terumo Cardiovascular Systems Corporation II Nov-13-2012

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