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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
  1.  K140012  SORIN FLEXTHERM
SORIN GROUP DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Microbial Contamination of Device 893
Device Displays Incorrect Message 347
Adverse Event Without Identified Device or Use Problem 137
Appropriate Term/Code Not Available 129
Insufficient Heating 111
Electrical /Electronic Property Problem 104
Device Operates Differently Than Expected 95
Other (for use when an appropriate device code cannot be identified) 91
Insufficient Cooling 89
Temperature Problem 71
Fluid Leak 64
Electrical Shorting 49
Device Stops Intermittently 38
Valve, Flow 37
Insufficient Information 30
Leak / Splash 28
Noise, Audible 24
Pumping Problem 23
Thermal Decomposition of Device 21
Device Issue 18
Device Operational Issue 18
Improper Flow or Infusion 17
Failure to Power Up 16
Biofilm coating in Device 16
No Flow 15
Failure to Pump 14
Overheating of Device 14
Mechanical Problem 14
Loss of Power 13
Infusion or Flow Problem 13
Pumping Stopped 12
Device Alarm System 11
Device Contamination With Biological Material 10
Device Inoperable 10
No Display / Image 10
Smoking 8
Use of Device Problem 8
Contamination During Use 8
Fuse 8
Pump 8
Partial Blockage 7
Device Contamination with Chemical or Other Material 7
Break 7
Power Problem 7
Device Reprocessing Problem 7
Connection Problem 7
Display or Visual Feedback Problem 6
Impedance Problem 5
Melted 5
Defective Component 5
Improper or Incorrect Procedure or Method 4
Corroded 4
Metal Shedding Debris 4
Electrical Power Problem 4
Switches 4
Device Disinfection Or Sterilization Issue 4
Loose or Intermittent Connection 4
Connector 4
Heater 4
Alarm, LED 4
Compressor (Air Pump) 4
Failure to Disinfect 3
Material Fragmentation 3
Unexpected Shutdown 3
Device Handling Problem 3
Pressure Problem 3
Motor 3
Resistor 3
Output Problem 3
Alarm, Audible 3
Restricted Flow rate 3
Circuit Failure 3
Failure to Calibrate 3
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 3
Circuit Breaker 3
False Alarm 3
Electronic Property Issue 3
Material Integrity Problem 3
Tee 3
Gas Leak 3
PC (Printed Circuit) Board 2
Calcified 2
Material Disintegration 2
Failure to Prime 2
Missing Information 2
Valve 2
Misconnection 2
No Apparent Adverse Event 2
Obstruction of Flow 2
Maintenance Does Not Comply To Manufacturers Recommendations 2
Unknown (for use when the device problem is not known) 2
Mixer 2
Occlusion Within Device 2
Temperature Sensor 2
Insufficient Flow or Under Infusion 2
Device Damaged Prior to Use 2
Calibration Problem 2
Failure to Shut Off 2
Failure To Run On AC/DC 2
Low Audible Alarm 2
Total Device Problems 2846

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

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