TPLC - Total Product Life Cycle

• 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 Code: DWC
• Regulation Number: 870.4250
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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