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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
2019 697 697
2020 548 548
2021 622 622
2022 605 605
2023 927 927
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 1834 1834
Temperature Problem 315 315
Pumping Problem 267 267
Electrical Shorting 180 180
Insufficient Cooling 147 147
Insufficient Heating 115 115
Fluid/Blood Leak 108 108
Appropriate Term/Code Not Available 108 108
Smoking 43 43
Pumping Stopped 38 38
No Flow 26 26
Adverse Event Without Identified Device or Use Problem 24 24
Insufficient Information 24 24
Unexpected Shutdown 22 22
Contamination 22 22
Electrical /Electronic Property Problem 21 21
Device Emits Odor 21 21
Infusion or Flow Problem 20 20
Leak/Splash 18 18
Overheating of Device 17 17
Failure to Pump 17 17
Device Alarm System 14 14
Biofilm coating in Device 13 13
Noise, Audible 11 11
Melted 10 10
Output Problem 9 9
Therapeutic or Diagnostic Output Failure 8 8
Excessive Cooling 8 8
Contamination /Decontamination Problem 7 7
Device Displays Incorrect Message 7 7
Excessive Heating 7 7
Sparking 6 6
Failure to Power Up 6 6
Defective Device 6 6
Mechanical Problem 6 6
Break 6 6
Circuit Failure 6 6
Display or Visual Feedback Problem 6 6
Incorrect, Inadequate or Imprecise Result or Readings 5 5
No Apparent Adverse Event 5 5
Power Problem 5 5
Defective Component 4 4
Device Sensing Problem 4 4
Device Contamination with Chemical or Other Material 4 4
No Display/Image 4 4
Gas Output Problem 4 4
Labelling, Instructions for Use or Training Problem 4 4
Gas/Air Leak 3 3
Failure of Device to Self-Test 3 3
Difficult to Open or Close 3 3
Arcing 3 3
Calibration Problem 3 3
Use of Device Problem 3 3
Ambient Temperature Problem 3 3
Fail-Safe Did Not Operate 3 3
Complete Loss of Power 3 3
Intermittent Loss of Power 3 3
Key or Button Unresponsive/not Working 2 2
Material Integrity Problem 2 2
Detachment of Device or Device Component 2 2
Protective Measures Problem 2 2
Blocked Connection 2 2
Self-Activation or Keying 2 2
Insufficient Flow or Under Infusion 2 2
Loss of Power 2 2
Incorrect Measurement 2 2
Erratic or Intermittent Display 2 2
Corroded 2 2
Thermal Decomposition of Device 2 2
False Alarm 2 2
No Audible Alarm 1 1
Alarm Not Visible 1 1
Complete Blockage 1 1
Crack 1 1
Degraded 1 1
Material Discolored 1 1
Material Disintegration 1 1
Unintended Collision 1 1
Energy Output Problem 1 1
Filling Problem 1 1
Fire 1 1
Restricted Flow rate 1 1
Material Fragmentation 1 1
Image Display Error/Artifact 1 1
Improper or Incorrect Procedure or Method 1 1
Material Rupture 1 1
Fumes or Vapors 1 1
Electrical Overstress 1 1
Electrical Power Problem 1 1
Communication or Transmission Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Unintended Movement 1 1
Patient Device Interaction Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Pressure Problem 1 1
Operating System Becomes Nonfunctional 1 1
Unintended Electrical Shock 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1853 1853
No Patient Involvement 471 471
No Known Impact Or Consequence To Patient 424 424
Bacterial Infection 343 343
No Consequences Or Impact To Patient 257 257
Insufficient Information 40 40
Death 32 32
Unspecified Infection 15 15
Alteration in Body Temperature 9 9
No Information 4 4
Multiple Organ Failure 3 3
Post Operative Wound Infection 3 3
Abdominal Pain 3 3
Fatigue 3 3
Endocarditis 3 3
Hypothermia 3 3
High Blood Pressure/ Hypertension 2 2
Fever 2 2
Abscess 2 2
Bradycardia 2 2
Sepsis 2 2
Respiratory Tract Infection 2 2
Alteration In Body Temperature 2 2
Unspecified Heart Problem 2 2
No Code Available 2 2
Weight Changes 2 2
Unspecified Gastrointestinal Problem 1 1
Renal Impairment 1 1
Lactate Dehydrogenase Increased 1 1
Patient Problem/Medical Problem 1 1
Test Result 1 1
Sweating 1 1
Abdominal Distention 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Uveitis 1 1
Ventricular Fibrillation 1 1
Vomiting 1 1
Weakness 1 1
Chills 1 1
Liver Damage/Dysfunction 1 1
Pain 1 1
Pneumothorax 1 1
Infection, Indirect 1 1
Arthralgia 1 1
Malaise 1 1
Disability 1 1
Impaired Healing 1 1
Ventilator Dependent 1 1
Numbness 1 1
Cardiopulmonary Arrest 1 1
Atrial Fibrillation 1 1
Diarrhea 1 1
Dyspnea 1 1
Non specific EKG/ECG Changes 1 1
Hearing Impairment 1 1
Hemorrhage/Bleeding 1 1
Hepatitis 1 1
Erythema 1 1
Fainting 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CardioQuip, LLC II Dec-15-2023
2 CardioQuip, LLC II Dec-01-2023
3 CardioQuip, LLC II Oct-07-2021
4 CardioQuip, LLC II Oct-06-2021
5 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Feb-13-2019
6 Gentherm Medical, LLC II Jul-19-2021
7 LivaNova Deutschland GmbH II Oct-06-2023
8 LivaNova USA Inc. II Mar-13-2020
9 LivaNova USA Inc. II Oct-25-2019
10 LivaNova USA Inc. II Apr-06-2019
11 Maquet Medical Systems USA II Jul-23-2021
12 Terumo Cardiovascular Systems Corporation II Jun-04-2021
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