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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
LIVANOVA DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Microbial Contamination of Device 1138
Device Displays Incorrect Message 299
Appropriate Term/Code Not Available 189
Adverse Event Without Identified Device or Use Problem 137
Insufficient Heating 101
Insufficient Cooling 95
Fluid Leak 93
Electrical /Electronic Property Problem 91
Electrical Shorting 85
Pumping Problem 76
Temperature Problem 73
Other (for use when an appropriate device code cannot be identified) 54
Device Operates Differently Than Expected 48
Insufficient Information 35
Device Stops Intermittently 27
Infusion or Flow Problem 26
Thermal Decomposition of Device 21
Noise, Audible 20
Pumping Stopped 20
Device Operational Issue 18
Failure to Pump 18
Failure to Power Up 18
Valve, Flow 18
Device Issue 18
Biofilm coating in Device 16
No Flow 14
Mechanical Problem 13
Loss of Power 13
Improper Flow or Infusion 12
Unexpected Shutdown 12
Melted 10
Device Contamination With Biological Material 10
No Display / Image 10
Fuse 8
Contamination During Use 8
Defective Component 8
Device Alarm System 8
Smoking 8
Power Problem 7
Overheating of Device 7
Leak / Splash 7
Display or Visual Feedback Problem 6
Device Contamination with Chemical or Other Material 6
Partial Blockage 6
Use of Device Problem 6
Break 5
Pump 5
Circuit Failure 5
Output Problem 5
Compressor (Air Pump) 4
Corroded 4
Device Reprocessing Problem 4
Device Disinfection Or Sterilization Issue 4
Electrical Power Problem 4
Metal Shedding Debris 4
Connector 3
Motor 3
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 3
Failure to Calibrate 3
Failure to Disinfect 3
Gas Leak 3
Material Integrity Problem 3
No Apparent Adverse Event 3
Excessive Cooling 3
Insufficient Flow or Under Infusion 3
Sparking 2
Calibration Problem 2
Connection Problem 2
Restricted Flow rate 2
Alarm, Audible 2
Missing Information 2
Arcing 2
Detachment of Device or device Component 2
Device Damaged Prior to Use 2
Material Fragmentation 2
Communication or Transmission Problem 2
Plug 2
Mixer 2
Temperature Sensor 2
Device Handling Problem 2
Material Disintegration 2
Switches 2
Knob 1
Panel 1
Adapter (Adaptor) 1
Power Switch 1
Failure To Run On AC/DC 1
Improper Device Output 1
Device Abrasion From Instrument Or Another Object 1
Failure to Prime 1
Material Puncture / Hole 1
Bearings 1
Crack 1
Occlusion Within Device 1
Electronic Property Issue 1
Mechanical Jam 1
Circuit Breaker 1
Excessive Heating 1
Image Display Error / Artifact 1
Product Quality Problem 1
Total Device Problems 3039

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 Mar-13-2020
7 LivaNova USA Inc. II Oct-25-2019
8 LivaNova USA Inc. II Apr-06-2019
9 Maquet Cardiovascular Us Sales, Llc II Nov-03-2016
10 Maquet Cardiovascular Us Sales, Llc II Jan-05-2016
11 Sorin Group USA, Inc. II Jul-25-2017
12 Sorin Group USA, Inc. II Dec-01-2016
13 Sorin Group USA, Inc. II Mar-17-2016
14 Sorin Group USA, Inc. II Jul-15-2015
15 Terumo Cardiovascular Systems Corporation II Apr-18-2018
16 Terumo Cardiovascular Systems Corporation II Jul-14-2016
17 Terumo Cardiovascular Systems Corporation II Jun-26-2015
18 Terumo Cardiovascular Systems Corporation II Feb-13-2015

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