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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

Device Problems
Microbial Contamination of Device 1024
Device Displays Incorrect Message 299
Appropriate Term/Code Not Available 187
Adverse Event Without Identified Device or Use Problem 137
Electrical /Electronic Property Problem 89
Insufficient Heating 88
Fluid Leak 85
Insufficient Cooling 82
Electrical Shorting 76
Temperature Problem 55
Other (for use when an appropriate device code cannot be identified) 54
Device Operates Differently Than Expected 48
Insufficient Information 32
Device Stops Intermittently 27
Pumping Problem 24
Infusion or Flow Problem 22
Thermal Decomposition of Device 21
Noise, Audible 20
Device Operational Issue 18
Failure to Power Up 18
Valve, Flow 18
Device Issue 18
Biofilm coating in Device 16
Pumping Stopped 15
Failure to Pump 14
No Flow 14
Mechanical Problem 13
Loss of Power 13
Improper Flow or Infusion 12
Device Contamination With Biological Material 10
No Display / Image 10
Unexpected Shutdown 9
Melted 8
Device Alarm System 8
Fuse 8
Contamination During Use 8
Defective Component 7
Leak / Splash 7
Smoking 7
Device Contamination with Chemical or Other Material 6
Partial Blockage 6
Power Problem 6
Use of Device Problem 6
Display or Visual Feedback Problem 6
Overheating of Device 6
Break 5
Pump 5
Device Reprocessing Problem 4
Device Disinfection Or Sterilization Issue 4
Electrical Power Problem 4
Metal Shedding Debris 4
Corroded 4
Compressor (Air Pump) 4
Circuit Failure 4
No Apparent Adverse Event 3
Excessive Cooling 3
Insufficient Flow or Under Infusion 3
Output Problem 3
Connector 3
Motor 3
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 3
Gas Leak 3
Material Integrity Problem 3
Failure to Disinfect 3
Failure to Calibrate 3
Plug 2
Mixer 2
Temperature Sensor 2
Device Handling Problem 2
Material Disintegration 2
Switches 2
Missing Information 2
Device Damaged Prior to Use 2
Material Fragmentation 2
Sparking 2
Calibration Problem 2
Connection Problem 2
Restricted Flow rate 2
Alarm, Audible 2
Intermittent Continuity 1
Moisture Damage 1
Particulates 1
Improper or Incorrect Procedure or Method 1
Activation, Positioning or Separation Problem 1
Contamination / decontamination Problem 1
Stepper Motor 1
False Alarm 1
Charred 1
Loose or Intermittent Connection 1
Component Missing 1
Issue With Displayed Error Message 1
Maintenance Does Not Comply To Manufacturers Recommendations 1
Device Difficult to Maintain 1
Erratic or Intermittent Display 1
Device Emits Odor 1
Obstruction of Flow 1
Arcing 1
Detachment of Device or device Component 1
Knob 1
Panel 1
Total Device Problems 2777

Recalls
Manufacturer Recall Class Date Posted
1 Cincinnati Sub-Zero Products Inc II Apr-15-2017
2 Cincinnati Sub-Zero Products LLC II Feb-13-2018
3 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Feb-13-2019
4 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Oct-03-2018
5 LivaNova USA II May-18-2018
6 LivaNova USA Inc. II Oct-25-2019
7 LivaNova USA Inc. II Apr-06-2019
8 Maquet Cardiovascular Us Sales, Llc II Nov-03-2016
9 Maquet Cardiovascular Us Sales, Llc II Jan-05-2016
10 Sorin Group USA, Inc. II Jul-25-2017
11 Sorin Group USA, Inc. II Dec-01-2016
12 Sorin Group USA, Inc. II Mar-17-2016
13 Sorin Group USA, Inc. II Jul-15-2015
14 Terumo Cardiovascular Systems Corporation II Apr-18-2018
15 Terumo Cardiovascular Systems Corporation II Jul-14-2016
16 Terumo Cardiovascular Systems Corporation II Jun-26-2015
17 Terumo Cardiovascular Systems Corporation II Feb-13-2015

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