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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 414
Device displays error message 245
Device operates differently than expected 193
Insufficient heating 146
Other (for use when an appropriate device code cannot be identified) 94
Insufficient cooling 83
No Known Device Problem 80
Temperature issue 75
Leak 63
Device stops intermittently 48
Electrical issue 37
Ambient noise issue 37
Fluid leak 31
No Information 29
Device alarm system issue 28
Infusion or flow issue 21
Improper flow or infusion 19
Component missing 19
No flow 18
Fracture 18
Biofilm coating in device 15
Failure to pump 14
Failure to power-up 13
Device inoperable 13
Break 13
Torn material 13
Pumping issue 11
Overheating of device or device component 11
Mechanical issue 10
Noise, Audible 10
Device Issue 10
Connection issue 9
Power source issue 8
Incorrect or inadequate result 8
Corrosion 8
Contamination during use 8
Device Cleaning Issue 7
Burn of device or device component 6
Blockage within device or device component 6
Material discolored 6
Incorrect display 6
Pumping stopped 6
Smoking 6
Foreign material present in device 5
Calibration issue 5
No code available 5
Material Distortion 5
Impedance issue 5
Loose or intermittent connection 5
Crack 5
No display or display failure 4
Naturally worn 4
Device disinfection or sterilization issue 4
Loss of power 4
Failure to sense 4
Metal shedding debris 4
Improper or incorrect procedure or method 3
Overfill 3
Electrical shorting 3
Electronic property issue 3
Material integrity issue 3
Material torqued 3
Material deformation 3
Sediment, precipitate or deposit in device or device ingredient 3
Pressure issue 3
Circuit Failure 3
Erratic display 3
Material erosion 3
Restricted flowrate 3
Failure to disinfect 3
False alarm 3
Grounding malfunction 3
Use of Device Issue 3
Failure to prime 2
Material puncture 2
No device output 2
Occlusion within device 2
Device emits odor 2
Misconnection 2
Hole in material 2
Low audible alarm 2
Failure to run on AC/DC 2
Calcified 2
Device clogged 2
Inaccurate flowrate 2
Misassembled by Users 2
Device handling issue 2
Maintenance does not comply to manufacturers recommendations 2
Improper device output 2
Inappropriate or unexpected reset 2
Device sensing issue 2
Difficult to open or close 2
Free or unrestricted flow 2
Failure to shut off 2
Obstruction within device 2
Unknown (for use when the device problem is not known) 2
Device damaged prior to use 1
Low impedance 1
Insufficient flow or underinfusion 1
Failure to calibrate 1
Total Device Problems 2075

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 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Cincinnati Sub-Zero Products Inc II Apr-15-2017
2 MAQUET Inc. II Jan-25-2007
3 Maquet Cardiovascular Us Sales, Llc II Nov-03-2016
4 Maquet Cardiovascular Us Sales, Llc II Jan-05-2016
5 Sorin Group USA, Inc. II Dec-01-2016
6 Sorin Group USA, Inc. II Mar-17-2016
7 Sorin Group USA, Inc. II Jul-15-2015
8 Terumo Cardiovascular Systems Corporation II Jul-14-2016
9 Terumo Cardiovascular Systems Corporation II Jun-26-2015
10 Terumo Cardiovascular Systems Corporation II Feb-13-2015
11 Terumo Cardiovascular Systems Corporation II Jun-21-2013
12 Terumo Cardiovascular Systems Corporation II Nov-13-2012

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