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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
SORIN
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Microbial Contamination of Device 968
Device Displays Incorrect Message 347
Appropriate Term/Code Not Available 175
Adverse Event Without Identified Device or Use Problem 137
Insufficient Heating 115
Electrical /Electronic Property Problem 109
Insufficient Cooling 108
Device Operates Differently Than Expected 95
Temperature Problem 91
Other (for use when an appropriate device code cannot be identified) 91
Fluid Leak 87
Electrical Shorting 67
Device Stops Intermittently 38
Valve, Flow 37
Insufficient Information 31
Leak / Splash 29
Pumping Problem 26
Noise, Audible 24
Thermal Decomposition of Device 21
Infusion or Flow Problem 19
Device Operational Issue 18
Failure to Power Up 18
Device Issue 18
Improper Flow or Infusion 17
Mechanical Problem 17
No Flow 16
Biofilm coating in Device 16
Pumping Stopped 15
Overheating of Device 14
Failure to Pump 14
Loss of Power 13
Device Alarm System 11
Device Contamination With Biological Material 10
Device Inoperable 10
No Display / Image 10
Unexpected Shutdown 9
Power Problem 9
Smoking 8
Pump 8
Use of Device Problem 8
Fuse 8
Contamination During Use 8
Defective Component 7
Display or Visual Feedback Problem 7
Connection Problem 7
Break 7
Partial Blockage 7
Device Reprocessing Problem 7
Device Contamination with Chemical or Other Material 7
Melted 7
Impedance Problem 5
Circuit Failure 5
Compressor (Air Pump) 4
Loose or Intermittent Connection 4
Corroded 4
Improper or Incorrect Procedure or Method 4
Alarm, LED 4
Device Disinfection Or Sterilization Issue 4
Switches 4
Electrical Power Problem 4
Metal Shedding Debris 4
Connector 4
Heater 4
Motor 3
Electronic Property Issue 3
Circuit Breaker 3
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 3
Device Handling Problem 3
Material Integrity Problem 3
Failure to Calibrate 3
Failure to Disinfect 3
Gas Leak 3
Insufficient Flow or Under Infusion 3
Alarm, Audible 3
Restricted Flow rate 3
Resistor 3
Tee 3
False Alarm 3
Pressure Problem 3
Output Problem 3
Material Fragmentation 3
No Device Output 2
Device Damaged Prior to Use 2
Obstruction of Flow 2
Misassembly by Users 2
Missing Information 2
Valve 2
Valve, Control 2
Maintenance Does Not Comply To Manufacturers Recommendations 2
Failure to Shut Off 2
Sparking 2
Calibration Problem 2
Excessive Cooling 2
No Apparent Adverse Event 2
Calcified 2
Plug 2
Mixer 2
Unknown (for use when the device problem is not known) 2
Temperature Sensor 2
PC (Printed Circuit) Board 2
Total Device Problems 3092

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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