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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 928 928
2024 177 177

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 1943 1943
Temperature Problem 329 329
Pumping Problem 278 278
Electrical Shorting 189 189
Insufficient Cooling 153 153
Insufficient Heating 119 119
Fluid/Blood Leak 111 111
Appropriate Term/Code Not Available 108 108
Smoking 44 44
Pumping Stopped 40 40
No Flow 26 26
Adverse Event Without Identified Device or Use Problem 24 24
Insufficient Information 24 24
Unexpected Shutdown 23 23
Contamination 22 22
Electrical /Electronic Property Problem 21 21
Leak/Splash 21 21
Device Emits Odor 21 21
Infusion or Flow Problem 20 20
Failure to Pump 18 18
Overheating of Device 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
Device Displays Incorrect Message 7 7
Contamination /Decontamination Problem 7 7
Excessive Heating 7 7
No Apparent Adverse Event 6 6
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
Power Problem 5 5
Defective Component 4 4
Ambient Temperature Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Device Sensing Problem 4 4
No Display/Image 4 4
Gas Output Problem 4 4
Labelling, Instructions for Use or Training Problem 4 4
Difficult to Open or Close 3 3
Gas/Air Leak 3 3
Failure of Device to Self-Test 3 3
Calibration Problem 3 3
Use of Device Problem 3 3
Arcing 3 3
Complete Loss of Power 3 3
Intermittent Loss of Power 3 3
Fail-Safe Did Not Operate 3 3
Key or Button Unresponsive/not Working 2 2
Protective Measures Problem 2 2
Material Integrity Problem 2 2
Insufficient Flow or Under Infusion 2 2
Self-Activation or Keying 2 2
Loss of Power 2 2
Detachment of Device or Device Component 2 2
Blocked Connection 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
Communication or Transmission Problem 1 1
Electrical Overstress 1 1
Electrical Power Problem 1 1
Short Fill 1 1
Material Rupture 1 1
Improper or Incorrect Procedure or Method 1 1
Fumes or Vapors 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
Operating System Becomes Nonfunctional 1 1
Pressure Problem 1 1
Unintended Movement 1 1
Missing Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2002 2002
No Patient Involvement 471 471
No Known Impact Or Consequence To Patient 424 424
Bacterial Infection 351 351
No Consequences Or Impact To Patient 257 257
Insufficient Information 42 42
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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