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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 427 427

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 1453 1453
Device Displays Incorrect Message 372 372
Temperature Problem 219 219
Appropriate Term/Code Not Available 186 186
Adverse Event Without Identified Device or Use Problem 180 180
Pumping Problem 166 166
Insufficient Heating 134 134
Fluid Leak 125 125
Electrical Shorting 114 114
Insufficient Cooling 102 102
Device Operates Differently Than Expected 102 102
Electrical /Electronic Property Problem 85 85
Insufficient Information 62 62
Noise, Audible 31 31
Infusion or Flow Problem 29 29
Pumping Stopped 29 29
Contamination 29 29
Device Contamination with Chemical or Other Material 28 28
No Flow 28 28
Loss of Power 26 26
Smoking 24 24
Failure to Power Up 21 21
Failure to Pump 20 20
Thermal Decomposition of Device 20 20
Biofilm coating in Device 18 18
No Display/Image 18 18
Melted 17 17
Device Issue 17 17
Device Inoperable 17 17
Unexpected Shutdown 16 16
Overheating of Device 15 15
Leak/Splash 14 14
Mechanical Problem 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 Alarm System 11 11
Device Operational Issue 11 11
Defective Component 10 10
Output Problem 9 9
Use of Device Problem 8 8
Defective Device 8 8
Display or Visual Feedback Problem 8 8
Break 8 8
Improper Flow or Infusion 7 7
Therapeutic or Diagnostic Output Failure 7 7
Electrical Power Problem 7 7
Power Problem 6 6
Contamination /Decontamination Problem 6 6
Insufficient Flow or Under Infusion 6 6
Circuit Failure 6 6
Corroded 6 6
Maintenance Does Not Comply To Manufacturers Recommendations 6 6
Excessive Cooling 5 5
Device Reprocessing Problem 5 5
Loose or Intermittent Connection 5 5
Material Integrity Problem 5 5
Impedance Problem 4 4
Device Sensing Problem 4 4
Excessive Heating 4 4
Improper or Incorrect Procedure or Method 4 4
Incorrect Measurement 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Sparking 4 4
Gas Leak 3 3
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 3 3
Material Fragmentation 3 3
Degraded 3 3
Failure to Disinfect 3 3
Calcified 3 3
No Apparent Adverse Event 3 3
Alarm Not Visible 3 3
Device Stops Intermittently 3 3
Arcing 3 3
Self-Activation or Keying 3 3
Partial Blockage 3 3
False Alarm 2 2
Image Display Error/Artifact 2 2
Device Maintenance Issue 2 2
Device Damaged Prior to Use 2 2
Low impedance 2 2
Missing Information 2 2
Key or Button Unresponsive/not Working 2 2
Connection Problem 2 2
Ambient Temperature Problem 2 2
Electronic Property Issue 2 2
Device Handling Problem 2 2
Intermittent Loss of Power 2 2
Material Disintegration 2 2
Complete Blockage 2 2
Fracture 2 2
Crack 2 2
Fire 2 2
Nonstandard Device 2 2
Shipping Damage or Problem 2 2
Failure to Prime 2 2
Protective Measures Problem 2 2
Detachment of Device or Device Component 2 2
Patient-Device Incompatibility 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 377 377
No Clinical Signs, Symptoms or Conditions 286 286
Death 84 84
No Information 57 57
Unspecified Infection 47 47
Fever 28 28
Endocarditis 21 21
Fatigue 21 21
Post Operative Wound Infection 16 16
Weight Changes 13 13
Abscess 12 12
Insufficient Information 12 12
Patient Problem/Medical Problem 7 7
Pneumonia 7 7
Weakness 6 6
No Code Available 6 6
Alteration in Body Temperature 6 6
Sepsis 6 6
Sweating 5 5
Pain 5 5
Multiple Organ Failure 4 4
Malaise 3 3
Renal Failure 3 3
Chills 3 3
Inflammation 3 3
Erythema 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
Hemorrhage/Bleeding 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
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
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
Fainting 1 1
Fall 1 1
Anemia 1 1
Aortic Insufficiency 1 1
Cardiopulmonary Arrest 1 1
Decreased Apgar 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
Hypoglycemia 1 1
Headache 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 CardioQuip, LLC II Oct-07-2021
2 CardioQuip, LLC II Oct-06-2021
3 Cincinnati Sub-Zero Products Inc II Apr-15-2017
4 Cincinnati Sub-Zero Products LLC II Feb-13-2018
5 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Feb-13-2019
6 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Oct-03-2018
7 Gentherm Medical, LLC II Jul-19-2021
8 LivaNova USA II May-18-2018
9 LivaNova USA Inc. II Mar-13-2020
10 LivaNova USA Inc. II Oct-25-2019
11 LivaNova USA Inc. II Apr-06-2019
12 Maquet Cardiovascular Us Sales, Llc II Nov-03-2016
13 Maquet Cardiovascular Us Sales, Llc II Jan-05-2016
14 Maquet Medical Systems USA II Jul-23-2021
15 Sorin Group USA, Inc. II Jul-25-2017
16 Sorin Group USA, Inc. II Dec-01-2016
17 Sorin Group USA, Inc. II Mar-17-2016
18 Terumo Cardiovascular Systems Corporation II Jun-04-2021
19 Terumo Cardiovascular Systems Corporation II Apr-18-2018
20 Terumo Cardiovascular Systems Corporation II Jul-14-2016
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