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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
Device operates differently than expected 191
Device displays error message 188
Bacterial contamination of device 145
Insufficient heating 133
Other (for use when an appropriate device code cannot be identified) 94
Insufficient cooling 81
Temperature issue 72
Leak 63
Device stops intermittently 48
Ambient noise issue 37
Electrical issue 36
Fluid leak 30
Device alarm system issue 27
Infusion or flow issue 21
No Known Device Problem 21
No Information 20
Component missing 19
Improper flow or infusion 19
Fracture 18
No flow 15
Torn material 13
Break 13
Device inoperable 13
Failure to pump 13
Failure to power-up 13
Overheating of device or device component 11
Noise, Audible 10
Connection issue 9
Mechanical issue 9
Incorrect or inadequate result 8
Power source issue 8
Pumping issue 8
Device Cleaning Issue 7
Corrosion 7
Material discolored 6
Incorrect display 6
Smoking 6
Device Issue 6
Calibration issue 5
Impedance issue 5
Material Distortion 5
Crack 5
Contamination during use 5
Biofilm coating in device 5
Loose or intermittent connection 5
Pumping stopped 4
Loss of power 4
Failure to sense 4
Metal shedding debris 4
Blockage within device or device component 4
No display or display failure 4
Naturally worn 4
No code available 4
Device disinfection or sterilization issue 4
Electrical shorting 3
Overfill 3
Pressure issue 3
Material torqued 3
Material deformation 3
Circuit Failure 3
Failure to disinfect 3
Erratic display 3
Grounding malfunction 3
Material erosion 3
Restricted flowrate 3
False alarm 3
Burn of device or device component 3
Improper or incorrect procedure or method 3
Use of Device Issue 3
Material puncture 2
Failure to prime 2
Misconnection 2
Hole in material 2
Occlusion within device 2
Device emits odor 2
Device clogged 2
Low audible alarm 2
Failure to run on AC/DC 2
Inaccurate flowrate 2
Maintenance does not comply to manufacturers recommendations 2
Material integrity issue 2
Misassembled by Users 2
Device handling issue 2
Unknown (for use when the device problem is not known) 2
Electronic property issue 2
Device sensing issue 2
Difficult to open or close 2
Improper device output 2
Inappropriate or unexpected reset 2
Failure to shut off 2
Foreign material present in device 2
Free or unrestricted flow 2
Gas leak 1
Failure of device to self-test 1
Device or device component damaged by another device 1
Device damaged prior to use 1
Low impedance 1
Communication or transmission issue 1
Obstruction within device 1
Failure to calibrate 1
Total Device Problems 1614

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

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