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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
2018 566 566
2019 697 697
2020 548 548
2021 622 622
2022 605 605
2023 806 806

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 1909 1909
Temperature Problem 305 305
Pumping Problem 264 264
Electrical Shorting 189 189
Appropriate Term/Code Not Available 185 185
Insufficient Cooling 154 154
Insufficient Heating 130 130
Fluid/Blood Leak 120 120
Device Displays Incorrect Message 99 99
Adverse Event Without Identified Device or Use Problem 52 52
Electrical /Electronic Property Problem 51 51
Smoking 45 45
Pumping Stopped 35 35
No Flow 28 28
Insufficient Information 26 26
Infusion or Flow Problem 25 25
Device Emits Odor 24 24
Contamination 23 23
Unexpected Shutdown 23 23
Failure to Pump 22 22
Overheating of Device 21 21
Leak/Splash 18 18
Noise, Audible 17 17
Device Alarm System 15 15
Biofilm coating in Device 13 13
Melted 13 13
Thermal Decomposition of Device 12 12
Device Operates Differently Than Expected 11 11
Output Problem 10 10
Display or Visual Feedback Problem 10 10
Mechanical Problem 10 10
Defective Component 9 9
Device Issue 8 8
Loss of Power 8 8
Failure to Power Up 8 8
No Display/Image 8 8
Therapeutic or Diagnostic Output Failure 8 8
Excessive Cooling 8 8
Excessive Heating 7 7
Break 7 7
Defective Device 7 7
Contamination /Decontamination Problem 7 7
Sparking 6 6
Use of Device Problem 6 6
Circuit Failure 6 6
Power Problem 6 6
No Apparent Adverse Event 5 5
Device Sensing Problem 5 5
Device Contamination with Chemical or Other Material 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Gas Output Problem 4 4
Labelling, Instructions for Use or Training Problem 4 4
Electrical Power Problem 4 4
Gas/Air Leak 3 3
Difficult to Open or Close 3 3
Failure of Device to Self-Test 3 3
Fail-Safe Did Not Operate 3 3
Complete Loss of Power 3 3
Intermittent Loss of Power 3 3
Self-Activation or Keying 3 3
Product Quality Problem 3 3
Ambient Temperature Problem 3 3
Calibration Problem 3 3
Arcing 3 3
Insufficient Flow or Under Infusion 3 3
Blocked Connection 2 2
Incorrect Measurement 2 2
Image Display Error/Artifact 2 2
Material Fragmentation 2 2
Complete Blockage 2 2
False Alarm 2 2
Erratic or Intermittent Display 2 2
Corroded 2 2
Missing Information 2 2
Key or Button Unresponsive/not Working 2 2
Detachment of Device or Device Component 2 2
Device Contamination With Biological Material 2 2
Improper Flow or Infusion 2 2
Material Integrity Problem 2 2
Protective Measures Problem 2 2
Pressure Problem 1 1
Operating System Becomes Nonfunctional 1 1
Unintended Movement 1 1
Patient Device Interaction Problem 1 1
Device Handling Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Device Operational Issue 1 1
Electrical Overstress 1 1
Unintended Application Program Shut Down 1 1
Activation Problem 1 1
Unintended Electrical Shock 1 1
No Visual Prompts/Feedback 1 1
Radiation Output Problem 1 1
Crack 1 1
Degraded 1 1
Material Discolored 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1722 1722
No Patient Involvement 705 705
No Known Impact Or Consequence To Patient 591 591
Bacterial Infection 374 374
No Consequences Or Impact To Patient 348 348
Death 47 47
Insufficient Information 40 40
Unspecified Infection 23 23
No Information 11 11
Fatigue 9 9
Fever 9 9
Endocarditis 8 8
Alteration in Body Temperature 8 8
Weight Changes 6 6
Abscess 4 4
Sepsis 4 4
Abdominal Pain 3 3
Hypothermia 3 3
Post Operative Wound Infection 3 3
Multiple Organ Failure 3 3
Weakness 3 3
Respiratory Tract Infection 2 2
Alteration In Body Temperature 2 2
Malaise 2 2
Unspecified Heart Problem 2 2
No Code Available 2 2
Pneumonia 2 2
Dyspnea 2 2
High Blood Pressure/ Hypertension 2 2
Bradycardia 2 2
Erythema 2 2
Fainting 1 1
Fall 1 1
Granuloma 1 1
Hearing Impairment 1 1
Hemorrhage/Bleeding 1 1
Hepatitis 1 1
Hypersensitivity/Allergic reaction 1 1
Cardiopulmonary Arrest 1 1
Diarrhea 1 1
Anemia 1 1
Aortic Insufficiency 1 1
Atrial Fibrillation 1 1
Hypoglycemia 1 1
Non specific EKG/ECG Changes 1 1
Inflammation 1 1
Liver Damage/Dysfunction 1 1
Pain 1 1
Pleural Effusion 1 1
Pneumothorax 1 1
Thrombus 1 1
Uveitis 1 1
Ventricular Fibrillation 1 1
Vomiting 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Gastrointestinal Problem 1 1
Renal Impairment 1 1
Lactate Dehydrogenase Increased 1 1
Diaphoresis 1 1
Abdominal Distention 1 1
Test Result 1 1
Not Applicable 1 1
Disability 1 1
Impaired Healing 1 1
Ventilator Dependent 1 1
Numbness 1 1
Infection, Indirect 1 1
Anxiety 1 1
Complaint, Ill-Defined 1 1
Arthralgia 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Sweating 1 1
Misdiagnosis 1 1
Chills 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CardioQuip, LLC II Dec-01-2023
2 CardioQuip, LLC II Oct-07-2021
3 CardioQuip, LLC II Oct-06-2021
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 Deutschland GmbH II Oct-06-2023
9 LivaNova USA II May-18-2018
10 LivaNova USA Inc. II Mar-13-2020
11 LivaNova USA Inc. II Oct-25-2019
12 LivaNova USA Inc. II Apr-06-2019
13 Maquet Medical Systems USA II Jul-23-2021
14 Terumo Cardiovascular Systems Corporation II Jun-04-2021
15 Terumo Cardiovascular Systems Corporation II Apr-18-2018
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