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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
CARDIOQUIP LLP
  SUBSTANTIALLY EQUIVALENT 1
CINCINNATI SUB-ZERO PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LIVANOVA DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 2
MAQUET CARDIOPULMONARY AG
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 378 378
2015 575 575
2016 786 786
2017 716 716
2018 566 566
2019 697 697
2020 548 548
2021 622 622
2022 605 605
2023 927 927
2024 127 127

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 2718 2718
Device Displays Incorrect Message 563 563
Temperature Problem 455 455
Pumping Problem 305 305
Insufficient Heating 263 263
Insufficient Cooling 253 253
Device Operates Differently Than Expected 212 212
Electrical Shorting 203 203
Appropriate Term/Code Not Available 193 193
Adverse Event Without Identified Device or Use Problem 191 191
Fluid/Blood Leak 191 191
Electrical /Electronic Property Problem 124 124
Other (for use when an appropriate device code cannot be identified) 91 91
Insufficient Information 84 84
No Flow 62 62
Leak/Splash 57 57
Pumping Stopped 57 57
Smoking 54 54
Contamination 48 48
Noise, Audible 45 45
Device Stops Intermittently 44 44
Overheating of Device 40 40
Infusion or Flow Problem 39 39
Failure to Pump 32 32
Device Emits Odor 31 31
Device Alarm System 31 31
Thermal Decomposition of Device 31 31
Device Inoperable 31 31
Device Contamination with Chemical or Other Material 30 30
Loss of Power 30 30
Biofilm coating in Device 29 29
Failure to Power Up 27 27
Improper Flow or Infusion 25 25
Unexpected Shutdown 25 25
Mechanical Problem 23 23
No Display/Image 23 23
Melted 22 22
Device Operational Issue 18 18
Device Issue 18 18
Display or Visual Feedback Problem 16 16
Break 14 14
Contamination of Device Ingredient or Reagent 13 13
Power Problem 13 13
Excessive Cooling 12 12
Device Contamination With Biological Material 12 12
Product Quality Problem 12 12
Circuit Failure 12 12
Device Reprocessing Problem 12 12
Corroded 11 11
Use of Device Problem 11 11
Defective Component 10 10
Defective Device 10 10
Output Problem 10 10
Connection Problem 9 9
Impedance Problem 9 9
Maintenance Does Not Comply To Manufacturers Recommendations 8 8
Electrical Power Problem 8 8
Improper or Incorrect Procedure or Method 8 8
Loose or Intermittent Connection 8 8
Therapeutic or Diagnostic Output Failure 8 8
Excessive Heating 7 7
No Apparent Adverse Event 7 7
Incorrect Measurement 7 7
Partial Blockage 7 7
False Alarm 7 7
Contamination /Decontamination Problem 7 7
Material Integrity Problem 7 7
Failure of Device to Self-Test 6 6
Device Disinfection Or Sterilization Issue 6 6
Device Sensing Problem 6 6
Sparking 6 6
Insufficient Flow or Under Infusion 6 6
Metal Shedding Debris 5 5
Incorrect, Inadequate or Imprecise Result or Readings 5 5
Calibration Problem 5 5
Calcified 5 5
Degraded 5 5
No Device Output 5 5
Failure to Prime 5 5
Labelling, Instructions for Use or Training Problem 5 5
Device Maintenance Issue 4 4
Restricted Flow rate 4 4
Material Fragmentation 4 4
Gas Output Problem 4 4
Failure to Disinfect 4 4
Electronic Property Issue 4 4
Gas/Air Leak 4 4
Arcing 4 4
Ambient Temperature Problem 4 4
Pressure Problem 4 4
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 3 3
Misassembly by Users 3 3
Positioning Problem 3 3
Device Handling Problem 3 3
Complete Loss of Power 3 3
Intermittent Loss of Power 3 3
Fail-Safe Did Not Operate 3 3
Low impedance 3 3
Obstruction of Flow 3 3
Failure to Calibrate 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1956 1956
No Known Impact Or Consequence To Patient 1375 1375
No Patient Involvement 1341 1341
No Consequences Or Impact To Patient 928 928
Bacterial Infection 556 556
No Information 108 108
Death 91 91
Unspecified Infection 62 62
Not Applicable 48 48
Insufficient Information 41 41
No Patient involvement 33 33
Fever 29 29
Endocarditis 26 26
Fatigue 21 21
Post Operative Wound Infection 18 18
Abscess 15 15
Weight Changes 14 14
Alteration in Body Temperature 9 9
Patient Problem/Medical Problem 7 7
No Code Available 7 7
Pneumonia 7 7
Sepsis 7 7
Weakness 6 6
Ventricular Fibrillation 5 5
Pain 5 5
Inflammation 5 5
Multiple Organ Failure 5 5
Sweating 5 5
Injury 5 5
Thromboembolism 4 4
Chills 3 3
Impaired Healing 3 3
Malaise 3 3
Complaint, Ill-Defined 3 3
Hepatitis 3 3
Hypothermia 3 3
Renal Failure 3 3
Wound Dehiscence 3 3
Abdominal Pain 3 3
Granuloma 3 3
Erythema 3 3
Dyspnea 3 3
Diarrhea 2 2
Purulent Discharge 2 2
Fistula 2 2
Arrhythmia 2 2
Cellulitis 2 2
Stroke/CVA 2 2
Bradycardia 2 2
Burn(s) 2 2
Thrombus 2 2
Misdiagnosis 2 2
Hemorrhage/Bleeding 2 2
High Blood Pressure/ Hypertension 2 2
Pleural Effusion 2 2
Respiratory Tract Infection 2 2
Respiratory Failure 2 2
Vomiting 2 2
Arthralgia 2 2
Pseudoaneurysm 2 2
Alteration In Body Temperature 2 2
Fluid Discharge 2 2
Pericardial Effusion 2 2
Unspecified Heart Problem 2 2
Unspecified Gastrointestinal Problem 1 1
Renal Impairment 1 1
Lactate Dehydrogenase Increased 1 1
Foreign Body In Patient 1 1
Bowel Perforation 1 1
Ventilator Dependent 1 1
Numbness 1 1
Loss of consciousness 1 1
Abdominal Distention 1 1
Diaphoresis 1 1
Disability 1 1
Test Result 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Pneumothorax 1 1
Left Ventricular Failure 1 1
Liver Damage/Dysfunction 1 1
Muscle Weakness 1 1
Myocardial Infarction 1 1
Nausea 1 1
Hyperthermia 1 1
Hypoglycemia 1 1
Low Blood Pressure/ Hypotension 1 1
Hypersensitivity/Allergic reaction 1 1
Blurred Vision 1 1
Discharge 1 1
Myalgia 1 1
Infection, Indirect 1 1
Anxiety 1 1
Discomfort 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Uveitis 1 1
Respiratory Distress 1 1
Septic Shock 1 1
Cardiac Arrest 1 1
Cardiopulmonary Arrest 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 Inc II Apr-15-2017
6 Cincinnati Sub-Zero Products LLC II Feb-13-2018
7 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Feb-13-2019
8 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Oct-03-2018
9 Gentherm Medical, LLC II Jul-19-2021
10 LivaNova Deutschland GmbH II Oct-06-2023
11 LivaNova USA II May-18-2018
12 LivaNova USA Inc. II Mar-13-2020
13 LivaNova USA Inc. II Oct-25-2019
14 LivaNova USA Inc. II Apr-06-2019
15 Maquet Cardiovascular Us Sales, Llc II Nov-03-2016
16 Maquet Cardiovascular Us Sales, Llc II Jan-05-2016
17 Maquet Medical Systems USA II Jul-23-2021
18 Sorin Group USA, Inc. II Jul-25-2017
19 Sorin Group USA, Inc. II Dec-01-2016
20 Sorin Group USA, Inc. II Mar-17-2016
21 Sorin Group USA, Inc. II Jul-15-2015
22 Terumo Cardiovascular Systems Corporation II Jun-04-2021
23 Terumo Cardiovascular Systems Corporation II Apr-18-2018
24 Terumo Cardiovascular Systems Corporation II Jul-14-2016
25 Terumo Cardiovascular Systems Corporation II Jun-26-2015
26 Terumo Cardiovascular Systems Corporation II Feb-13-2015
27 Terumo Cardiovascular Systems Corporation II Jun-21-2013
28 Terumo Cardiovascular Systems Corporation II Nov-13-2012
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