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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
2016 786 786
2017 716 716
2018 566 566
2019 697 697
2020 548 548
2021 127 127

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 1317 1317
Device Displays Incorrect Message 372 372
Appropriate Term/Code Not Available 185 185
Temperature Problem 180 180
Adverse Event Without Identified Device or Use Problem 177 177
Pumping Problem 130 130
Insufficient Heating 122 122
Fluid Leak 118 118
Device Operates Differently Than Expected 102 102
Electrical Shorting 101 101
Electrical /Electronic Property Problem 84 84
Insufficient Cooling 83 83
Insufficient Information 54 54
Noise, Audible 31 31
Infusion or Flow Problem 28 28
Pumping Stopped 28 28
No Flow 27 27
Contamination 27 27
Device Contamination with Chemical or Other Material 27 27
Loss of Power 26 26
Failure to Power Up 20 20
Failure to Pump 20 20
Thermal Decomposition of Device 20 20
Smoking 18 18
Melted 17 17
Device Issue 17 17
Device Inoperable 17 17
Biofilm coating in Device 15 15
No Display/Image 15 15
Unexpected Shutdown 14 14
Leak/Splash 14 14
Overheating of Device 13 13
Mechanical Problem 12 12
Product Quality Problem 12 12
Device Contamination With Biological Material 12 12
Contamination of Device Ingredient or Reagent 11 11
Device Emits Odor 11 11
Device Operational Issue 11 11
Defective Component 10 10
Defective Device 8 8
Output Problem 8 8
Use of Device Problem 8 8
Break 8 8
Improper Flow or Infusion 7 7
Device Alarm System 7 7
Electrical Power Problem 7 7
Power Problem 6 6
Circuit Failure 6 6
Insufficient Flow or Under Infusion 6 6
Maintenance Does Not Comply To Manufacturers Recommendations 6 6
Therapeutic or Diagnostic Output Failure 6 6
Display or Visual Feedback Problem 6 6
Device Reprocessing Problem 5 5
Loose or Intermittent Connection 5 5
Corroded 5 5
Contamination /Decontamination Problem 5 5
Material Integrity Problem 5 5
Impedance Problem 4 4
Device Sensing Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Incorrect Measurement 4 4
Excessive Cooling 4 4
Gas Leak 3 3
Sparking 3 3
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 3 3
Incorrect, Inadequate or Imprecise Resultor Readings 3 3
Degraded 3 3
Failure to Disinfect 3 3
Calcified 3 3
Material Fragmentation 3 3
No Apparent Adverse Event 3 3
Arcing 3 3
Partial Blockage 3 3
Device Stops Intermittently 3 3
Excessive Heating 3 3
Missing Information 2 2
Connection Problem 2 2
Electronic Property Issue 2 2
False Alarm 2 2
Alarm Not Visible 2 2
Ambient Temperature Problem 2 2
Device Damaged Prior to Use 2 2
Low impedance 2 2
Device Maintenance Issue 2 2
Self-Activation or Keying 2 2
Device Handling Problem 2 2
Intermittent Loss of Power 2 2
Gas Output Problem 2 2
Fracture 2 2
Crack 2 2
Fire 2 2
Material Disintegration 2 2
Complete Blockage 2 2
Shipping Damage or Problem 2 2
Failure to Prime 2 2
Nonstandard Device 2 2
Detachment of Device or Device Component 2 2
Failure to Calibrate 2 2
Patient-Device Incompatibility 2 2
Component Missing 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 1182 1182
No Patient Involvement 1055 1055
No Consequences Or Impact To Patient 628 628
Bacterial Infection 336 336
Death 84 84
No Information 57 57
Unspecified Infection 45 45
No Clinical Signs, Symptoms or Conditions 39 39
Fever 28 28
Endocarditis 21 21
Fatigue 21 21
Post Operative Wound Infection 16 16
Weight Changes 13 13
Abscess 12 12
Patient Problem/Medical Problem 7 7
Pneumonia 7 7
Weakness 6 6
No Code Available 6 6
Sepsis 6 6
Sweating 5 5
Alteration in Body Temperature 5 5
Pain 5 5
Complaint, Ill-Defined 3 3
Granuloma 3 3
Malaise 3 3
Renal Failure 3 3
Chills 3 3
Inflammation 3 3
Wound Dehiscence 3 3
Dyspnea 3 3
Hepatitis 3 3
Multiple Organ Failure 3 3
Pericardial Effusion 2 2
Fluid Discharge 2 2
Respiratory Failure 2 2
Erythema 2 2
Thrombus 2 2
Misdiagnosis 2 2
Cellulitis 2 2
Stroke/CVA 2 2
Diarrhea 2 2
Purulent Discharge 2 2
Fistula 2 2
Injury 2 2
Arthralgia 2 2
Pleural Effusion 2 2
Ventricular Fibrillation 2 2
Impaired Healing 2 2
Alteration In Body Temperature 2 2
Abdominal Pain 2 2
Vomiting 2 2
Pseudoaneurysm 1 1
Foreign Body In Patient 1 1
Test Result 1 1
Not Applicable 1 1
Blurred Vision 1 1
Respiratory Distress 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Uveitis 1 1
Disability 1 1
Myalgia 1 1
Infection, Indirect 1 1
Anxiety 1 1
Discomfort 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
Septic Shock 1 1
Left Ventricular Failure 1 1
Muscle Weakness 1 1
Hematoma 1 1
Discharge 1 1
Numbness 1 1
Loss of consciousness 1 1
Diaphoresis 1 1
Fainting 1 1
Fall 1 1
Anemia 1 1
Aortic Insufficiency 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
Bowel Perforation 1 1
Insufficient Information 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 Terumo Cardiovascular Systems Corporation II Apr-18-2018
15 Terumo Cardiovascular Systems Corporation II Jul-14-2016
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