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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
2017 716 716
2018 566 566
2019 697 697
2020 548 548
2021 622 622

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 1329 1329
Device Displays Incorrect Message 207 207
Temperature Problem 203 203
Appropriate Term/Code Not Available 185 185
Pumping Problem 175 175
Electrical Shorting 125 125
Adverse Event Without Identified Device or Use Problem 124 124
Insufficient Heating 108 108
Insufficient Cooling 104 104
Fluid Leak 102 102
Electrical /Electronic Property Problem 82 82
Device Operates Differently Than Expected 42 42
Pumping Stopped 30 30
Infusion or Flow Problem 27 27
Insufficient Information 27 27
Smoking 25 25
Noise, Audible 22 22
Unexpected Shutdown 18 18
Overheating of Device 18 18
Failure to Pump 18 18
Contamination 18 18
Thermal Decomposition of Device 18 18
Failure to Power Up 16 16
No Flow 16 16
Loss of Power 15 15
No Display/Image 14 14
Leak/Splash 13 13
Mechanical Problem 12 12
Melted 12 12
Device Issue 12 12
Product Quality Problem 11 11
Device Contamination With Biological Material 11 11
Device Emits Odor 10 10
Device Inoperable 10 10
Defective Component 10 10
Biofilm coating in Device 10 10
Output Problem 9 9
Device Alarm System 8 8
Display or Visual Feedback Problem 8 8
Break 7 7
Defective Device 7 7
Therapeutic or Diagnostic Output Failure 7 7
Excessive Heating 6 6
Contamination /Decontamination Problem 6 6
Electrical Power Problem 6 6
Device Contamination with Chemical or Other Material 6 6
Circuit Failure 6 6
Use of Device Problem 6 6
Sparking 5 5
Excessive Cooling 5 5
Device Sensing Problem 4 4
Impedance Problem 4 4
Improper Flow or Infusion 4 4
Power Problem 4 4
Insufficient Flow or Under Infusion 4 4
Incorrect Measurement 4 4
Incorrect, Inadequate or Imprecise Resultor Readings 4 4
Self-Activation or Keying 3 3
Gas Output Problem 3 3
Device Stops Intermittently 3 3
Gas Leak 3 3
Device Operational Issue 3 3
Arcing 3 3
No Apparent Adverse Event 3 3
Protective Measures Problem 2 2
Missing Information 2 2
Key or Button Unresponsive/not Working 2 2
Intermittent Loss of Power 2 2
Detachment of Device or Device Component 2 2
Difficult to Open or Close 2 2
Improper or Incorrect Procedure or Method 2 2
Patient-Device Incompatibility 2 2
Ambient Temperature Problem 2 2
Failure to Calibrate 2 2
Component Missing 2 2
Shipping Damage or Problem 2 2
Device Reprocessing Problem 2 2
Complete Blockage 2 2
Crack 2 2
Material Disintegration 2 2
Fracture 2 2
Material Fragmentation 2 2
Fire 2 2
Loose or Intermittent Connection 2 2
Image Display Error/Artifact 2 2
Kinked 1 1
Device Abrasion From Instrument Or Another Object 1 1
Nonstandard Device 1 1
Restricted Flow rate 1 1
Filling Problem 1 1
Erratic or Intermittent Display 1 1
Corroded 1 1
Partial Blockage 1 1
Component Incompatible 1 1
False Alarm 1 1
No Audible Alarm 1 1
Alarm Not Visible 1 1
Failure to Read Input Signal 1 1
Sticking 1 1
Material Rupture 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 Consequences Or Impact To Patient 458 458
No Clinical Signs, Symptoms or Conditions 447 447
Bacterial Infection 342 342
Death 69 69
Unspecified Infection 31 31
No Information 26 26
Fever 22 22
Fatigue 21 21
Insufficient Information 15 15
Post Operative Wound Infection 14 14
Weight Changes 13 13
Endocarditis 11 11
Weakness 6 6
Alteration in Body Temperature 6 6
Abscess 5 5
Pain 5 5
Sweating 4 4
Multiple Organ Failure 4 4
No Code Available 3 3
Sepsis 3 3
Chills 3 3
Complaint, Ill-Defined 3 3
Erythema 3 3
Dyspnea 3 3
Wound Dehiscence 2 2
Pleural Effusion 2 2
Pneumonia 2 2
Renal Failure 2 2
Vomiting 2 2
Abdominal Pain 2 2
Ventricular Fibrillation 2 2
Alteration In Body Temperature 2 2
Arthralgia 2 2
Malaise 2 2
Pericardial Effusion 2 2
Patient Problem/Medical Problem 2 2
Disability 1 1
Numbness 1 1
Loss of consciousness 1 1
Diaphoresis 1 1
Respiratory Failure 1 1
Fluid Discharge 1 1
Foreign Body In Patient 1 1
Test Result 1 1
Not Applicable 1 1
Blurred Vision 1 1
Misdiagnosis 1 1
Thrombus 1 1
Uveitis 1 1
Injury 1 1
Myalgia 1 1
Infection, Indirect 1 1
Anxiety 1 1
Discomfort 1 1
Respiratory Distress 1 1
Inflammation 1 1
Left Ventricular Failure 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

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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