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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.
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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 493
Device displays error message 289
Device operates differently than expected 194
Insufficient heating 149
No Known Device Problem 109
Other (for use when an appropriate device code cannot be identified) 94
Insufficient cooling 84
Temperature issue 78
Leak 63
Device stops intermittently 48
Electrical issue 45
Ambient noise issue 37
Fluid leak 32
No Information 30
Device alarm system issue 28
Infusion or flow issue 21
Improper flow or infusion 19
Component missing 19
No flow 18
Fracture 18
Failure to power-up 18
Failure to pump 16
Biofilm coating in device 16
Break 13
Device inoperable 13
Pumping issue 13
Torn material 13
Noise, Audible 12
Device Issue 11
Overheating of device or device component 11
Burn of device or device component 11
Mechanical issue 10
Connection issue 9
Device Contamination with biological material 8
Power source issue 8
Pumping stopped 8
Incorrect or inadequate result 8
No display or display failure 8
Corrosion 8
Contamination during use 8
Device Cleaning Issue 7
Smoking 7
Loss of power 7
Blockage within device or device component 6
Material discolored 6
Incorrect display 6
Crack 5
Loose or intermittent connection 5
Electrical shorting 5
Calibration issue 5
No code available 5
Foreign material present in device 5
Impedance issue 5
Material Distortion 5
Naturally worn 4
Device disinfection or sterilization issue 4
Failure to sense 4
Metal shedding debris 4
Improper or incorrect procedure or method 3
Overfill 3
Electronic property issue 3
Electrical power problem 3
Material deformation 3
Material integrity issue 3
Material torqued 3
Pressure issue 3
Sediment, precipitate or deposit in device or device ingredient 3
Grounding malfunction 3
Use of Device Issue 3
Failure to disinfect 3
Circuit Failure 3
Erratic display 3
Material erosion 3
Restricted flowrate 3
False alarm 3
Low audible alarm 2
Failure to run on AC/DC 2
Device clogged 2
Calcified 2
Inaccurate flowrate 2
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
Device handling issue 2
Misassembled by Users 2
Failure to shut off 2
Maintenance does not comply to manufacturers recommendations 2
Improper device output 2
Free or unrestricted flow 2
Inappropriate or unexpected reset 2
Device sensing issue 2
Difficult to open or close 2
Obstruction within device 2
Failure to calibrate 2
Insufficient flow or underinfusion 2
Unknown (for use when the device problem is not known) 2
Total Device Problems 2286

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 2
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 Jul-25-2017
6 Sorin Group USA, Inc. II Dec-01-2016
7 Sorin Group USA, Inc. II Mar-17-2016
8 Sorin Group USA, Inc. II Jul-15-2015
9 Terumo Cardiovascular Systems Corporation II Jul-14-2016
10 Terumo Cardiovascular Systems Corporation II Jun-26-2015
11 Terumo Cardiovascular Systems Corporation II Feb-13-2015
12 Terumo Cardiovascular Systems Corporation II Jun-21-2013
13 Terumo Cardiovascular Systems Corporation II Nov-13-2012

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