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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 277 277

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 1386 1386
Device Displays Incorrect Message 372 372
Temperature Problem 200 200
Appropriate Term/Code Not Available 186 186
Adverse Event Without Identified Device or Use Problem 180 180
Pumping Problem 152 152
Insufficient Heating 128 128
Fluid Leak 121 121
Electrical Shorting 108 108
Device Operates Differently Than Expected 102 102
Insufficient Cooling 96 96
Electrical /Electronic Property Problem 84 84
Insufficient Information 61 61
Noise, Audible 31 31
Infusion or Flow Problem 29 29
Pumping Stopped 29 29
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 21 21
Failure to Pump 20 20
Smoking 20 20
Thermal Decomposition of Device 20 20
Device Inoperable 17 17
Melted 17 17
Device Issue 17 17
No Display/Image 16 16
Unexpected Shutdown 15 15
Biofilm coating in Device 15 15
Leak/Splash 14 14
Mechanical Problem 13 13
Overheating of Device 13 13
Device Emits Odor 12 12
Product Quality Problem 12 12
Device Contamination With Biological Material 12 12
Contamination of Device Ingredient or Reagent 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
Therapeutic or Diagnostic Output Failure 7 7
Improper Flow or Infusion 7 7
Device Alarm System 7 7
Electrical Power Problem 7 7
Contamination /Decontamination Problem 6 6
Power Problem 6 6
Circuit Failure 6 6
Corroded 6 6
Insufficient Flow or Under Infusion 6 6
Maintenance Does Not Comply To Manufacturers Recommendations 6 6
Display or Visual Feedback Problem 6 6
Device Reprocessing Problem 5 5
Excessive Cooling 5 5
Loose or Intermittent Connection 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, Inadequate or Imprecise Resultor Readings 4 4
Incorrect Measurement 4 4
Degraded 3 3
Failure to Disinfect 3 3
Calcified 3 3
Material Fragmentation 3 3
Gas Leak 3 3
Sparking 3 3
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 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
Image Display Error/Artifact 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
Detachment of Device or Device Component 2 2
Failure to Calibrate 2 2
Patient-Device Incompatibility 2 2
Component Missing 2 2
Calibration Problem 2 2
Fracture 2 2
Crack 2 2
Fire 2 2
Material Disintegration 2 2
Complete Blockage 2 2
Nonstandard Device 2 2
Shipping Damage or Problem 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 627 627
Bacterial Infection 356 356
No Clinical Signs, Symptoms or Conditions 166 166
Death 84 84
No Information 57 57
Unspecified Infection 45 45
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
Insufficient Information 6 6
Sweating 5 5
Alteration in Body Temperature 5 5
Pain 5 5
Multiple Organ Failure 4 4
Malaise 3 3
Renal Failure 3 3
Chills 3 3
Inflammation 3 3
Wound Dehiscence 3 3
Dyspnea 3 3
Hepatitis 3 3
Granuloma 3 3
Complaint, Ill-Defined 3 3
Injury 2 2
Arthralgia 2 2
Impaired Healing 2 2
Alteration In Body Temperature 2 2
Diarrhea 2 2
Purulent Discharge 2 2
Fistula 2 2
Cellulitis 2 2
Stroke/CVA 2 2
Pleural Effusion 2 2
Ventricular Fibrillation 2 2
Abdominal Pain 2 2
Vomiting 2 2
Erythema 2 2
Thrombus 2 2
Misdiagnosis 2 2
Pericardial Effusion 2 2
Respiratory Failure 2 2
Fluid Discharge 2 2
Bowel Perforation 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
High Blood Pressure/ Hypertension 1 1
Hyperthermia 1 1
Low Blood Pressure/ Hypotension 1 1
Non specific EKG/ECG Changes 1 1
Blurred Vision 1 1
Myalgia 1 1
Infection, Indirect 1 1
Anxiety 1 1
Discomfort 1 1
Myocardial Infarction 1 1
Nausea 1 1
Respiratory Distress 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Uveitis 1 1
Stacking Breaths 1 1
Syncope 1 1
Exposure to Body Fluids 1 1
Bradycardia 1 1
Cardiac Arrest 1 1
Headache 1 1
Hemorrhage/Bleeding 1 1
Hypoglycemia 1 1
Foreign Body In Patient 1 1
Test Result 1 1
Not Applicable 1 1
Pseudoaneurysm 1 1
Disability 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 Gentherm Medical, LLC II Jul-19-2021
6 LivaNova USA II May-18-2018
7 LivaNova USA Inc. II Mar-13-2020
8 LivaNova USA Inc. II Oct-25-2019
9 LivaNova USA Inc. II Apr-06-2019
10 Maquet Cardiovascular Us Sales, Llc II Nov-03-2016
11 Maquet Cardiovascular Us Sales, Llc II Jan-05-2016
12 Maquet Medical Systems USA II Jul-23-2021
13 Sorin Group USA, Inc. II Jul-25-2017
14 Sorin Group USA, Inc. II Dec-01-2016
15 Sorin Group USA, Inc. II Mar-17-2016
16 Terumo Cardiovascular Systems Corporation II Jun-04-2021
17 Terumo Cardiovascular Systems Corporation II Apr-18-2018
18 Terumo Cardiovascular Systems Corporation II Jul-14-2016
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