Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
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 928 928
2024 336 336

Device Problems MDRs with this Device Problem Events in those MDRs
Microbial Contamination of Device 2853 2853
Device Displays Incorrect Message 511 511
Temperature Problem 432 432
Pumping Problem 313 313
Insufficient Cooling 233 233
Insufficient Heating 230 230
Electrical Shorting 216 216
Appropriate Term/Code Not Available 193 193
Adverse Event Without Identified Device or Use Problem 191 191
Fluid/Blood Leak 182 182
Device Operates Differently Than Expected 159 159
Electrical /Electronic Property Problem 103 103
Insufficient Information 84 84
Pumping Stopped 64 64
No Flow 58 58
Other (for use when an appropriate device code cannot be identified) 54 54
Smoking 50 50
Contamination 48 48
Noise, Audible 41 41
Leak/Splash 36 36
Infusion or Flow Problem 34 34
Overheating of Device 32 32
Failure to Pump 31 31
Device Emits Odor 31 31
Thermal Decomposition of Device 31 31
Device Stops Intermittently 31 31
Loss of Power 29 29
Biofilm coating in Device 29 29
Device Contamination with Chemical or Other Material 29 29
Device Alarm System 27 27
Unexpected Shutdown 25 25
Failure to Power Up 25 25
No Display/Image 23 23
Melted 22 22
Mechanical Problem 20 20
Improper Flow or Infusion 20 20
Device Inoperable 20 20
Device Issue 18 18
Device Operational Issue 18 18
Display or Visual Feedback Problem 14 14
Contamination of Device Ingredient or Reagent 13 13
Product Quality Problem 12 12
Break 12 12
Excessive Cooling 12 12
Device Contamination With Biological Material 12 12
Power Problem 12 12
Corroded 11 11
Output Problem 10 10
Circuit Failure 10 10
Defective Component 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2158 2158
No Known Impact Or Consequence To Patient 1272 1272
No Patient Involvement 1255 1255
No Consequences Or Impact To Patient 818 818
Bacterial Infection 564 564
No Information 103 103
Death 84 84
Unspecified Infection 61 61
Insufficient Information 42 42
Fever 29 29
Endocarditis 26 26
Fatigue 21 21
No Patient involvement 18 18
Post Operative Wound Infection 17 17
Abscess 15 15
Weight Changes 14 14
Alteration in Body Temperature 9 9
Patient Problem/Medical Problem 7 7
Pneumonia 7 7
No Code Available 7 7
Sepsis 7 7
Weakness 6 6
Pain 5 5
Injury 5 5
Multiple Organ Failure 5 5
Inflammation 5 5
Sweating 5 5
Hypothermia 3 3
Dyspnea 3 3
Granuloma 3 3
Erythema 3 3
Malaise 3 3
Renal Failure 3 3
Impaired Healing 3 3
Thromboembolism 3 3
Chills 3 3
Wound Dehiscence 3 3
Hepatitis 3 3
Abdominal Pain 3 3
Ventricular Fibrillation 3 3
Complaint, Ill-Defined 3 3
Respiratory Tract Infection 2 2
High Blood Pressure/ Hypertension 2 2
Stroke/CVA 2 2
Fluid Discharge 2 2
Vomiting 2 2
Pleural Effusion 2 2
Diarrhea 2 2
Bradycardia 2 2
Alteration In Body Temperature 2 2

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
-
-