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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 194
Device operates differently than expected 191
Bacterial contamination of device 148
Insufficient heating 136
Other (for use when an appropriate device code cannot be identified) 94
Insufficient cooling 82
Temperature issue 72
Leak 63
Device stops intermittently 48
Electrical issue 37
Ambient noise issue 37
Fluid leak 30
Device alarm system issue 27
No Known Device Problem 25
Infusion or flow issue 21
No Information 20
Improper flow or infusion 19
Component missing 19
Fracture 18
No flow 15
Torn material 13
Break 13
Device inoperable 13
Failure to power-up 13
Failure to pump 13
Overheating of device or device component 11
Noise, Audible 10
Connection issue 9
Mechanical issue 9
Incorrect or inadequate result 8
Pumping issue 8
Power source 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
Loose or intermittent connection 5
Contamination during use 5
Crack 5
Biofilm coating in device 5
Blockage within device or device component 4
Burn of device or device component 4
No display or display failure 4
Loss of power 4
Failure to sense 4
Pumping stopped 4
Naturally worn 4
No code available 4
Device disinfection or sterilization issue 4
Metal shedding debris 4
Improper or incorrect procedure or method 3
Electrical shorting 3
Overfill 3
Material torqued 3
Pressure issue 3
Material deformation 3
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
Low audible alarm 2
Failure to run on AC/DC 2
Device clogged 2
Inaccurate flowrate 2
Hole in material 2
Misconnection 2
Occlusion within device 2
Device emits odor 2
Material puncture 2
Failure to prime 2
Material integrity issue 2
Inappropriate or unexpected reset 2
Maintenance does not comply to manufacturers recommendations 2
Device handling issue 2
Misassembled by Users 2
Unknown (for use when the device problem is not known) 2
Electronic property issue 2
Improper device output 2
Failure to shut off 2
Foreign material present in device 2
Free or unrestricted flow 2
Device sensing issue 2
Difficult to open or close 2
Device or device component damaged by another device 1
Insufficient flow or underinfusion 1
Gas leak 1
Failure of device to self-test 1
Device damaged prior to use 1
Low impedance 1
Communication or transmission issue 1
Obstruction within device 1
Total Device Problems 1633

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 3
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 Jul-14-2016
6 Terumo Cardiovascular Systems Corporation II Jun-26-2015
7 Terumo Cardiovascular Systems Corporation II Feb-13-2015
8 Terumo Cardiovascular Systems Corporation II Jun-21-2013
9 Terumo Cardiovascular Systems Corporation II Nov-13-2012

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