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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

MDR Year MDR Reports MDR Events
2015 575 575
2016 786 786
2017 716 716
2018 566 566
2019 697 697
2020 426 426

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 1278 1278
Device Displays Incorrect Message 510 510
Appropriate Term/Code Not Available 191 191
Adverse Event Without Identified Device or Use Problem 179 179
Temperature Problem 167 167
Device Operates Differently Than Expected 159 159
Insufficient Heating 151 151
Fluid Leak 133 133
Insufficient Cooling 121 121
Pumping Problem 101 101
Electrical /Electronic Property Problem 97 97
Electrical Shorting 92 92
Insufficient Information 66 66
Other (for use when an appropriate device code cannot be identified) 54 54
Noise, Audible 38 38
No Flow 37 37
Valve, Flow 37 37
Infusion or Flow Problem 33 33
Pumping Stopped 32 32
Device Stops Intermittently 31 31
Thermal Decomposition of Device 30 30
Loss of Power 29 29
Device Contamination with Chemical or Other Material 28 28
Contamination 27 27
Failure to Power Up 23 23
No Display/Image 20 20
Improper Flow or Infusion 20 20
Device Inoperable 20 20
Leak/Splash 19 19
Pump 19 19
Failure to Pump 19 19
Device Issue 18 18
Melted 18 18
Device Operational Issue 18 18
Mechanical Problem 17 17
Overheating of Device 17 17
Heater 16 16
Biofilm coating in Device 16 16
Smoking 15 15
Device Alarm System 14 14
Fuse 14 14
Contamination of Device Ingredient or Reagent 13 13
Hose 13 13
Unexpected Shutdown 13 13
Device Emits Odor 12 12
Device Contamination With Biological Material 12 12
Product Quality Problem 12 12
Connector 12 12
Break 11 11
Display or Visual Feedback Problem 10 10
Defective Device 10 10
Defective Component 10 10
Temperature Sensor 10 10
Corroded 9 9
Device Reprocessing Problem 9 9
PC (Printed Circuit) Board 9 9
Use of Device Problem 8 8
Excessive Cooling 8 8
Circuit Failure 8 8
Power Problem 8 8
Electrical Power Problem 7 7
Switches 7 7
Maintenance Does Not Comply To Manufacturers Recommendations 7 7
Output Problem 7 7
Compressor 7 7
Therapeutic or Diagnostic Output Failure 6 6
Valve(s) 6 6
Sensor 6 6
Partial Blockage 6 6
Insufficient Flow or Under Infusion 6 6
Improper or Incorrect Procedure or Method 5 5
Loose or Intermittent Connection 5 5
Device Disinfection Or Sterilization Issue 5 5
Contamination /Decontamination Problem 5 5
Motor(s) 5 5
Material Integrity Problem 5 5
Metal Shedding Debris 5 5
Failure to Prime 4 4
Incorrect Measurement 4 4
Degraded 4 4
Failure to Disinfect 4 4
Alarm, Audible 4 4
Connection Problem 4 4
Impedance Problem 4 4
Arcing 4 4
Low impedance 3 3
Device Sensing Problem 3 3
Device Maintenance Issue 3 3
Circuit Board 3 3
Plug 3 3
False Alarm 3 3
Failure of Device to Self-Test 3 3
Thermostat 3 3
Excessive Heating 3 3
Calcified 3 3
Filter 3 3
Material Fragmentation 3 3
Crack 3 3
No Device Output 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1219 1219
No Patient Involvement 1187 1187
No Consequences Or Impact To Patient 772 772
Bacterial Infection 309 309
No Information 103 103
Death 77 77
Unspecified Infection 51 51
Fever 27 27
Endocarditis 26 26
Fatigue 20 20
No Patient involvement 18 18
Post Operative Wound Infection 17 17
Abscess 15 15
Weight Changes 13 13
No Code Available 7 7
Patient Problem/Medical Problem 7 7
Pneumonia 7 7
Weakness 6 6
Injury 5 5
Pain 5 5
Inflammation 5 5
Sepsis 5 5
Sweating 5 5
Wound Dehiscence 3 3
Dyspnea 3 3
Hepatitis 3 3
Renal Failure 3 3
Ventricular Fibrillation 3 3
Granuloma 3 3
Complaint, Ill-Defined 3 3
Thromboembolism 3 3
Alteration In Body Temperature 2 2
Impaired Healing 2 2
Pseudoaneurysm 2 2
Alteration in Body Temperature 2 2
Cellulitis 2 2
Stroke/CVA 2 2
Diarrhea 2 2
Purulent Discharge 2 2
Fistula 2 2
Pleural Effusion 2 2
Arthralgia 2 2
Abdominal Pain 2 2
Vomiting 2 2
Fluid Discharge 2 2
Multiple Organ Failure 2 2
Pericardial Effusion 2 2
Erythema 2 2
Respiratory Failure 2 2
Malaise 2 2
Thrombus 2 2
Misdiagnosis 2 2
Chills 2 2
Septic Shock 1 1
Left Ventricular Failure 1 1
Muscle Weakness 1 1
Hematoma 1 1
Numbness 1 1
Loss of consciousness 1 1
Discharge 1 1
Bowel Perforation 1 1
Diaphoresis 1 1
Fainting 1 1
Fall 1 1
Anemia 1 1
Aortic Insufficiency 1 1
Burn(s) 1 1
Cardiopulmonary Arrest 1 1
Decreased Apgar 1 1
Hypersensitivity/Allergic reaction 1 1
Hyperthermia 1 1
Low Blood Pressure/ Hypotension 1 1
Non specific EKG/ECG Changes 1 1
Disability 1 1
Myalgia 1 1
Infection, Indirect 1 1
Anxiety 1 1
Discomfort 1 1
Blurred Vision 1 1
Respiratory Distress 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Uveitis 1 1
Exposure to Body Fluids 1 1
Cardiac Arrest 1 1
Stacking Breaths 1 1
Syncope 1 1
Myocardial Infarction 1 1
Nausea 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Hypoglycemia 1 1
Test Result 1 1
Not Applicable 1 1
Foreign Body In Patient 1 1

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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