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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
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 2
SPECTRUM MEDICAL LTD.
  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 622 622
2022 512 512

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 1817 1817
Device Displays Incorrect Message 372 372
Temperature Problem 295 295
Pumping Problem 227 227
Appropriate Term/Code Not Available 187 187
Adverse Event Without Identified Device or Use Problem 181 181
Electrical Shorting 160 160
Insufficient Heating 160 160
Fluid/Blood Leak 150 150
Insufficient Cooling 140 140
Device Operates Differently Than Expected 102 102
Electrical /Electronic Property Problem 86 86
Insufficient Information 66 66
Smoking 45 45
Contamination 43 43
No Flow 38 38
Pumping Stopped 36 36
Noise, Audible 33 33
Device Emits Odor 29 29
Infusion or Flow Problem 29 29
Device Contamination with Chemical or Other Material 28 28
Overheating of Device 27 27
Biofilm coating in Device 27 27
Loss of Power 26 26
Failure to Pump 23 23
Unexpected Shutdown 22 22
Failure to Power Up 21 21
Melted 21 21
Thermal Decomposition of Device 21 21
Device Alarm System 20 20
No Display/Image 18 18
Device Inoperable 17 17
Device Issue 17 17
Leak/Splash 15 15
Mechanical Problem 14 14
Product Quality Problem 12 12
Device Contamination With Biological Material 12 12
Device Operational Issue 11 11
Contamination of Device Ingredient or Reagent 11 11
Defective Component 10 10
Output Problem 9 9
Display or Visual Feedback Problem 9 9
Use of Device Problem 8 8
Break 8 8
Power Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Defective Device 8 8
Excessive Cooling 8 8
Electrical Power Problem 7 7
Contamination /Decontamination Problem 7 7
Improper Flow or Infusion 7 7
Material Integrity Problem 7 7
Circuit Failure 7 7
Excessive Heating 7 7
Corroded 6 6
Insufficient Flow or Under Infusion 6 6
Maintenance Does Not Comply To Manufacturers Recommendations 6 6
Sparking 6 6
Device Sensing Problem 5 5
Loose or Intermittent Connection 5 5
Incorrect Measurement 5 5
Device Reprocessing Problem 5 5
False Alarm 4 4
Degraded 4 4
Gas Output Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Incorrect, Inadequate or Imprecise Result or Readings 4 4
Calibration Problem 4 4
Impedance Problem 4 4
No Apparent Adverse Event 4 4
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 3 3
Gas/Air Leak 3 3
Arcing 3 3
Difficult to Open or Close 3 3
Failure of Device to Self-Test 3 3
Self-Activation or Keying 3 3
Device Stops Intermittently 3 3
Material Fragmentation 3 3
Failure to Disinfect 3 3
Alarm Not Visible 3 3
Calcified 3 3
Partial Blockage 3 3
Intermittent Loss of Power 3 3
Fail-Safe Did Not Operate 3 3
Missing Information 2 2
Key or Button Unresponsive/not Working 2 2
Complete Loss of Power 2 2
Complete Blockage 2 2
Crack 2 2
Material Disintegration 2 2
Material Discolored 2 2
Fracture 2 2
Fire 2 2
Image Display Error/Artifact 2 2
Device Maintenance Issue 2 2
Nonstandard Device 2 2
Device Damaged Prior to Use 2 2
Low impedance 2 2
Shipping Damage or Problem 2 2
Failure to Prime 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 Clinical Signs, Symptoms or Conditions 945 945
No Consequences Or Impact To Patient 627 627
Bacterial Infection 428 428
Death 84 84
No Information 57 57
Unspecified Infection 49 49
Fever 29 29
Insufficient Information 25 25
Endocarditis 21 21
Fatigue 21 21
Post Operative Wound Infection 16 16
Weight Changes 14 14
Abscess 12 12
Alteration in Body Temperature 8 8
Patient Problem/Medical Problem 7 7
Pneumonia 7 7
Sepsis 7 7
Weakness 6 6
No Code Available 6 6
Multiple Organ Failure 5 5
Sweating 5 5
Pain 5 5
Renal Failure 3 3
Inflammation 3 3
Hepatitis 3 3
Hypothermia 3 3
Chills 3 3
Complaint, Ill-Defined 3 3
Wound Dehiscence 3 3
Abdominal Pain 3 3
Dyspnea 3 3
Erythema 3 3
Granuloma 3 3
Malaise 3 3
Impaired Healing 2 2
Respiratory Failure 2 2
Alteration In Body Temperature 2 2
Fluid Discharge 2 2
Pericardial Effusion 2 2
Fistula 2 2
High Blood Pressure/ Hypertension 2 2
Diarrhea 2 2
Purulent Discharge 2 2
Bradycardia 2 2
Cellulitis 2 2
Stroke/CVA 2 2
Injury 2 2
Arthralgia 2 2
Vomiting 2 2
Misdiagnosis 2 2
Ventricular Fibrillation 2 2
Thrombus 2 2
Hemorrhage/Bleeding 2 2
Pleural Effusion 2 2
Pneumothorax 1 1
Respiratory Distress 1 1
Septic Shock 1 1
Hypersensitivity/Allergic reaction 1 1
Left Ventricular Failure 1 1
Liver Damage/Dysfunction 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Nausea 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Uveitis 1 1
Blurred Vision 1 1
Discharge 1 1
Myalgia 1 1
Infection, Indirect 1 1
Anxiety 1 1
Discomfort 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 1 1
Decreased Apgar 1 1
Stacking Breaths 1 1
Syncope 1 1
Exposure to Body Fluids 1 1
Anemia 1 1
Aortic Insufficiency 1 1
Atrial Fibrillation 1 1
Hyperthermia 1 1
Hypoglycemia 1 1
Low Blood Pressure/ Hypotension 1 1
Headache 1 1
Hematoma 1 1
Fainting 1 1
Fall 1 1
Non specific EKG/ECG Changes 1 1
Unspecified Heart Problem 1 1
Unspecified Gastrointestinal Problem 1 1
Renal Impairment 1 1
Lactate Dehydrogenase Increased 1 1
Test Result 1 1
Not Applicable 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Foreign Body In Patient 1 1
Bowel Perforation 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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