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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 displays error message 213
Bacterial contamination of device 198
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 72
Leak 63
Device stops intermittently 48
No Known Device Problem 40
Ambient noise issue 37
Electrical issue 37
Fluid leak 31
Device alarm system issue 28
No Information 27
Infusion or flow issue 21
Component missing 19
Improper flow or infusion 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
Incorrect or inadequate result 8
Device Cleaning Issue 7
Corrosion 7
Device Issue 7
Contamination during use 6
Material discolored 6
Smoking 6
Incorrect display 6
Loose or intermittent connection 5
Pumping stopped 5
Crack 5
Calibration issue 5
Impedance issue 5
Material Distortion 5
No code available 5
Naturally worn 4
Foreign material present in device 4
Device disinfection or sterilization issue 4
Metal shedding debris 4
No display or display failure 4
Burn of device or device component 4
Blockage within device or device component 4
Failure to sense 4
Loss of power 4
Grounding malfunction 3
Use of Device Issue 3
False alarm 3
Circuit Failure 3
Material erosion 3
Restricted flowrate 3
Failure to disinfect 3
Erratic display 3
Improper or incorrect procedure or method 3
Electrical shorting 3
Electronic property issue 3
Overfill 3
Pressure issue 3
Material torqued 3
Material deformation 3
Failure to shut off 2
Maintenance does not comply to manufacturers recommendations 2
Material integrity issue 2
Device handling issue 2
Misassembled by Users 2
Obstruction within device 2
Unknown (for use when the device problem is not known) 2
Free or unrestricted flow 2
Improper device output 2
Inappropriate or unexpected reset 2
Device sensing issue 2
Difficult to open or close 2
Inaccurate flowrate 2
Low audible alarm 2
Failure to run on AC/DC 2
Calcified 2
Device clogged 2
Material puncture 2
Failure to prime 2
Hole in material 2
No device output 2
Misconnection 2
Occlusion within device 2
Device emits odor 2
Output above specifications 1
Moisture damage 1
Peeled 1
Excess flow or overinfusion 1
Device maintenance issue 1
Total Device Problems 1749

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 4
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 Nov-03-2016
3 Maquet Cardiovascular Us Sales, Llc II Jan-05-2016
4 Sorin Group USA, Inc. II Mar-17-2016
5 Sorin Group USA, Inc. II Jul-15-2015
6 Terumo Cardiovascular Systems Corporation II Jul-14-2016
7 Terumo Cardiovascular Systems Corporation II Jun-26-2015
8 Terumo Cardiovascular Systems Corporation II Feb-13-2015
9 Terumo Cardiovascular Systems Corporation II Jun-21-2013
10 Terumo Cardiovascular Systems Corporation II Nov-13-2012

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