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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 1
SPECTRUM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 716 716
2018 566 566
2019 697 697
2020 548 548
2021 622 622
2022 391 391

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 1533 1533
Temperature Problem 242 242
Pumping Problem 215 215
Device Displays Incorrect Message 207 207
Appropriate Term/Code Not Available 186 186
Electrical Shorting 153 153
Adverse Event Without Identified Device or Use Problem 125 125
Insufficient Cooling 123 123
Insufficient Heating 122 122
Fluid Leak 117 117
Electrical /Electronic Property Problem 83 83
Smoking 44 44
Device Operates Differently Than Expected 42 42
Pumping Stopped 33 33
Insufficient Information 30 30
Infusion or Flow Problem 27 27
Device Emits Odor 25 25
Contamination 23 23
Noise, Audible 23 23
Unexpected Shutdown 21 21
Overheating of Device 20 20
Failure to Pump 19 19
Biofilm coating in Device 19 19
Thermal Decomposition of Device 18 18
No Flow 17 17
Failure to Power Up 16 16
Loss of Power 15 15
Melted 15 15
No Display/Image 14 14
Device Alarm System 14 14
Leak/Splash 14 14
Mechanical Problem 13 13
Device Issue 12 12
Product Quality Problem 11 11
Device Contamination With Biological Material 11 11
Device Inoperable 10 10
Defective Component 10 10
Display or Visual Feedback Problem 9 9
Output Problem 9 9
Therapeutic or Diagnostic Output Failure 8 8
Defective Device 7 7
Break 7 7
Contamination /Decontamination Problem 7 7
Excessive Heating 7 7
Device Contamination with Chemical or Other Material 6 6
Sparking 6 6
Excessive Cooling 6 6
Electrical Power Problem 6 6
Circuit Failure 6 6
Use of Device Problem 6 6
Device Sensing Problem 5 5
Power Problem 4 4
Improper Flow or Infusion 4 4
Incorrect Measurement 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Impedance Problem 4 4
Insufficient Flow or Under Infusion 4 4
Self-Activation or Keying 3 3
Gas Output Problem 3 3
No Apparent Adverse Event 3 3
Calibration Problem 3 3
Fail-Safe Did Not Operate 3 3
Failure of Device to Self-Test 3 3
Arcing 3 3
Device Stops Intermittently 3 3
False Alarm 3 3
Gas Leak 3 3
Device Operational Issue 3 3
Patient-Device Incompatibility 2 2
Device Reprocessing Problem 2 2
Complete Blockage 2 2
Material Disintegration 2 2
Fire 2 2
Fracture 2 2
Material Fragmentation 2 2
Protective Measures Problem 2 2
Intermittent Loss of Power 2 2
Image Display Error/Artifact 2 2
Improper or Incorrect Procedure or Method 2 2
Ambient Temperature Problem 2 2
Missing Information 2 2
Blocked Connection 2 2
Component Missing 2 2
Failure to Calibrate 2 2
Detachment of Device or Device Component 2 2
Difficult to Open or Close 2 2
Crack 2 2
Shipping Damage or Problem 2 2
Loose or Intermittent Connection 2 2
Key or Button Unresponsive/not Working 2 2
Device Damaged Prior to Use 1 1
Output below Specifications 1 1
Material Rupture 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Moisture or Humidity Problem 1 1
Erratic or Intermittent Display 1 1
Restricted Flow rate 1 1
Kinked 1 1
Device Abrasion From Instrument Or Another Object 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 904 904
No Patient Involvement 861 861
No Clinical Signs, Symptoms or Conditions 822 822
No Consequences Or Impact To Patient 458 458
Bacterial Infection 360 360
Death 69 69
Unspecified Infection 33 33
No Information 26 26
Insufficient Information 25 25
Fever 22 22
Fatigue 21 21
Post Operative Wound Infection 14 14
Weight Changes 13 13
Endocarditis 11 11
Alteration in Body Temperature 8 8
Weakness 6 6
Abscess 5 5
Pain 5 5
Multiple Organ Failure 5 5
Sepsis 4 4
Sweating 4 4
Chills 3 3
Complaint, Ill-Defined 3 3
Abdominal Pain 3 3
Erythema 3 3
Dyspnea 3 3
No Code Available 3 3
Pericardial Effusion 2 2
Patient Problem/Medical Problem 2 2
Wound Dehiscence 2 2
Pleural Effusion 2 2
Pneumonia 2 2
Renal Failure 2 2
Ventricular Fibrillation 2 2
Hypothermia 2 2
Vomiting 2 2
Arthralgia 2 2
Malaise 2 2
Alteration In Body Temperature 2 2
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Diaphoresis 1 1
Respiratory Failure 1 1
Abdominal Distention 1 1
Disability 1 1
Ventilator Dependent 1 1
Numbness 1 1
Loss of consciousness 1 1
Injury 1 1
Misdiagnosis 1 1
Myalgia 1 1
Infection, Indirect 1 1
Anxiety 1 1
Discomfort 1 1
Blurred Vision 1 1
Thrombus 1 1
Uveitis 1 1
Respiratory Distress 1 1
Pneumothorax 1 1
Inflammation 1 1
Left Ventricular Failure 1 1
Liver Damage/Dysfunction 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Nausea 1 1
Fistula 1 1
Granuloma 1 1
Headache 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Hepatitis 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Hypoglycemia 1 1
Low Blood Pressure/ Hypotension 1 1
Stacking Breaths 1 1
Anemia 1 1
Aortic Insufficiency 1 1
Exposure to Body Fluids 1 1
Bradycardia 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 1 1
Stroke/CVA 1 1
Non specific EKG/ECG Changes 1 1
Diarrhea 1 1
Purulent Discharge 1 1
Fainting 1 1
Fall 1 1
Test Result 1 1
Not Applicable 1 1
Renal Impairment 1 1
Lactate Dehydrogenase Increased 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 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 Medical Systems USA II Jul-23-2021
13 Sorin Group USA, Inc. II Jul-25-2017
14 Terumo Cardiovascular Systems Corporation II Jun-04-2021
15 Terumo Cardiovascular Systems Corporation II Apr-18-2018
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