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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device console, heart-lung machine, cardiopulmonary bypass
Product CodeDTQ
Regulation Number 870.4220
Device Class 2


Premarket Reviews
ManufacturerDecision
CENTURY HLM, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIFEBRIDGE MEDIZINTECHNIK AG
  SUBSTANTIALLY EQUIVALENT 1
LIVANOVA DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 3
MAQUET CARDIOPULMONARY AG
  SUBSTANTIALLY EQUIVALENT 2
SORIN GROUP DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 4
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5

MDR Year MDR Reports MDR Events
2014 1290 1290
2015 1184 1184
2016 714 714
2017 526 526
2018 676 676
2019 857 857
2020 627 627
2021 729 729
2022 717 717
2023 814 814
2024 210 210

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 1046 1046
Output Problem 717 717
Device Operates Differently Than Expected 604 604
Pumping Stopped 439 439
Other (for use when an appropriate device code cannot be identified) 434 434
Device Alarm System 343 343
No Display/Image 321 321
Battery Problem 306 306
Display or Visual Feedback Problem 287 287
Failure to Calibrate 271 271
Pumping Problem 258 258
Mechanical Problem 204 204
Break 201 201
Calibration Problem 188 188
Power Problem 177 177
Difficult to Open or Close 171 171
Incorrect, Inadequate or Imprecise Result or Readings 165 165
Electrical /Electronic Property Problem 157 157
Charging Problem 135 135
Failure to Power Up 122 122
Pressure Problem 116 116
Infusion or Flow Problem 104 104
Device Sensing Problem 97 97
False Alarm 97 97
Communication or Transmission Problem 95 95
No Flow 95 95
Fluid/Blood Leak 94 94
Leak/Splash 87 87
Device Stops Intermittently 87 87
Appropriate Term/Code Not Available 85 85
Out-Of-Box Failure 75 75
Failure to Pump 74 74
Connection Problem 71 71
Device Inoperable 68 68
Failure to Read Input Signal 58 58
Loss of Power 57 57
Inadequate User Interface 54 54
Adverse Event Without Identified Device or Use Problem 53 53
Failure to Run on Battery 52 52
Mechanical Jam 50 50
Improper Flow or Infusion 49 49
Loose or Intermittent Connection 47 47
Insufficient Information 45 45
Noise, Audible 44 44
Use of Device Problem 44 44
Erratic or Intermittent Display 44 44
Inaccurate Flow Rate 41 41
Failure to Charge 40 40
Device Operational Issue 40 40
Protective Measures Problem 38 38
Unable to Obtain Readings 38 38
Fracture 35 35
Detachment Of Device Component 32 32
Unexpected Shutdown 32 32
Loss of or Failure to Bond 31 31
Material Deformation 30 30
Material Integrity Problem 27 27
Decoupling 27 27
Incorrect Measurement 27 27
Defective Alarm 23 23
Detachment of Device or Device Component 23 23
Thermal Decomposition of Device 22 22
Failure to Auto Stop 21 21
Maintenance Does Not Comply To Manufacturers Recommendations 21 21
Gas Output Problem 20 20
Failure to Sense 20 20
Application Program Freezes, Becomes Nonfunctional 19 19
Failure To Run On AC/DC 18 18
Air Leak 18 18
Alarm Not Visible 18 18
Failure To Adhere Or Bond 18 18
No Audible Alarm 17 17
Device Slipped 17 17
Issue With Displayed Error Message 17 17
Electrical Power Problem 17 17
Smoking 16 16
Circuit Failure 16 16
Overheating of Device 15 15
Temperature Problem 15 15
Gas/Air Leak 14 14
Problem with Software Installation 14 14
Improper or Incorrect Procedure or Method 14 14
Increase in Pressure 14 14
No Device Output 14 14
Defective Component 13 13
Intermittent Communication Failure 13 13
Positioning Problem 12 12
Improper Device Output 12 12
Component Missing 12 12
Low Battery 12 12
Electrical Shorting 12 12
Bent 12 12
Crack 12 12
Degraded 11 11
Insufficient Flow or Under Infusion 11 11
Impedance Problem 11 11
Operating System Becomes Nonfunctional 10 10
Filtration Problem 10 10
Calibration Error 10 10
Insufficient Cooling 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2574 2574
No Clinical Signs, Symptoms or Conditions 2336 2336
No Patient Involvement 1666 1666
No Known Impact Or Consequence To Patient 1111 1111
Insufficient Information 209 209
No Patient involvement 202 202
No Information 127 127
Not Applicable 126 126
Death 100 100
Cardiac Arrest 42 42
Air Embolism 15 15
Blood Loss 12 12
Low Oxygen Saturation 11 11
Low Blood Pressure/ Hypotension 9 9
Brain Injury 7 7
Hemorrhage/Bleeding 7 7
Hematuria 6 6
No Code Available 6 6
Exsanguination 5 5
Cardiopulmonary Arrest 5 5
Arrhythmia 4 4
Neurological Deficit/Dysfunction 4 4
Asystole 4 4
Bronchial Hemorrhage 4 4
Ischemia 3 3
Injury 3 3
Peroneal Nerve Palsy 3 3
Bradycardia 3 3
Burn(s) 2 2
Bacterial Infection 2 2
Airway Obstruction 2 2
Hematoma 2 2
Intracranial Hemorrhage 2 2
Meningitis 2 2
Myocarditis 2 2
Collagen disease 2 2
Other (for use when an appropriate patient code cannot be identified) 2 2
Hypoxia 2 2
Respiratory Arrest 2 2
Multiple Organ Failure 2 2
Valvular Stenosis 2 2
Low Cardiac Output 2 2
Sudden Cardiac Death 1 1
Atrial Perforation 1 1
Respiratory Acidosis 1 1
Vascular System (Circulation), Impaired 1 1
Nervous System Injury 1 1
Shock from Patient Lead(s) 1 1
Embolism/Embolus 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Unspecified Infection 1 1
Respiratory Distress 1 1
Thrombus 1 1
Aortic valve replacement 1 1
Convulsion, Tonic 1 1
Hemolytic Anemia 1 1
Collapse 1 1
Coma 1 1
Post Operative Wound Infection 1 1
Pallor 1 1
Hemolysis 1 1
Congenital Defect/Deformity 1 1
Embolism 1 1
Anoxia 1 1
Abnormal Blood Gases 1 1
Wound Dehiscence 1 1

Recalls
Manufacturer Recall Class Date Posted
1 LivaNova USA Inc. III Feb-10-2020
2 Maquet Cardiovascular Us Sales, Llc I Mar-28-2019
3 Maquet Cardiovascular Us Sales, Llc II Apr-12-2016
4 Maquet Cardiovascular Us Sales, Llc II May-28-2015
5 Maquet Cardiovascular Us Sales, Llc II Nov-13-2014
6 Maquet Cardiovascular Us Sales, Llc II Feb-22-2011
7 Maquet Cardiovascular, LLC II Apr-18-2013
8 Maquet Inc. II Aug-29-2011
9 Maquet Inc. II Aug-22-2011
10 Maquet Medical Systems USA II Feb-08-2024
11 Maquet Medical Systems USA II Dec-21-2023
12 Maquet Medical Systems USA II Dec-14-2023
13 Maquet Medical Systems USA I Dec-07-2023
14 Maquet Medical Systems USA II Nov-09-2023
15 Maquet Medical Systems USA II May-26-2023
16 Maquet Medical Systems USA II Apr-08-2022
17 Maquet Medical Systems USA II Oct-25-2013
18 Salyer Prn Biomedical II Mar-01-2013
19 Sorin Group Deutschland GmbH II Jan-28-2014
20 Sorin Group Deutschland GmbH II Nov-04-2013
21 Sorin Group Deutschland GmbH II Mar-29-2012
22 Sorin Group USA, Inc. II Sep-21-2016
23 Sorin Group USA, Inc. II Nov-08-2012
24 Sorin Group USA, Inc. II Mar-05-2012
25 Sorin Group USA, Inc. II Jan-26-2011
26 Sorin Group USA, Inc. II Jul-22-2010
27 Spectrum Medical Ltd. I Aug-23-2019
28 Terumo Cardiovascular Systems Corporation II Aug-26-2021
29 Terumo Cardiovascular Systems Corporation II Sep-12-2020
30 Terumo Cardiovascular Systems Corporation II Feb-07-2020
31 Terumo Cardiovascular Systems Corporation II Jun-11-2019
32 Terumo Cardiovascular Systems Corporation II May-15-2019
33 Terumo Cardiovascular Systems Corporation II Oct-18-2018
34 Terumo Cardiovascular Systems Corporation II Sep-25-2018
35 Terumo Cardiovascular Systems Corporation II Apr-20-2018
36 Terumo Cardiovascular Systems Corporation II Mar-14-2017
37 Terumo Cardiovascular Systems Corporation II May-28-2015
38 Terumo Cardiovascular Systems Corporation II Jul-08-2014
39 Terumo Cardiovascular Systems Corporation II Aug-15-2013
40 Terumo Cardiovascular Systems Corporation II Aug-14-2013
41 Terumo Cardiovascular Systems Corporation II Aug-14-2013
42 Terumo Cardiovascular Systems Corporation II Nov-27-2012
43 Terumo Cardiovascular Systems Corporation II Nov-13-2012
44 Terumo Cardiovascular Systems Corporation II Oct-24-2012
45 Terumo Cardiovascular Systems Corporation II Sep-25-2012
46 Terumo Cardiovascular Systems Corporation II Sep-24-2012
47 Terumo Cardiovascular Systems Corporation II Sep-11-2012
48 Terumo Cardiovascular Systems Corporation II Aug-21-2012
49 Terumo Cardiovascular Systems Corporation III Aug-16-2012
50 Terumo Cardiovascular Systems Corporation II Aug-09-2012
51 Terumo Cardiovascular Systems Corporation II Jul-20-2012
52 Terumo Cardiovascular Systems Corporation II Jul-19-2012
53 Terumo Cardiovascular Systems Corporation II Jul-17-2012
54 Terumo Cardiovascular Systems Corporation II Jul-13-2012
55 Terumo Cardiovascular Systems Corporation II Jul-09-2012
56 Terumo Cardiovascular Systems Corporation II Jul-09-2012
57 Terumo Cardiovascular Systems Corporation II Jul-09-2012
58 Terumo Cardiovascular Systems Corporation II Jul-09-2012
59 Terumo Cardiovascular Systems Corporation II Jul-06-2012
60 Terumo Cardiovascular Systems Corporation II Apr-23-2012
61 Terumo Cardiovascular Systems Corporation II Mar-27-2012
62 Terumo Cardiovascular Systems Corporation II Jan-24-2012
63 Terumo Cardiovascular Systems Corporation II Nov-29-2011
64 Terumo Cardiovascular Systems Corporation II Nov-29-2011
65 Terumo Cardiovascular Systems Corporation II Jul-06-2011
66 Terumo Cardiovascular Systems Corporation II Jun-22-2011
67 Terumo Cardiovascular Systems Corporation II Mar-07-2011
68 Terumo Cardiovascular Systems Corporation II Jan-07-2011
69 Terumo Cardiovascular Systems Corporation II Sep-23-2010
70 Terumo Cardiovascular Systems Corporation II May-29-2009
71 Terumo Cardiovascular Systems Corporation II Feb-24-2009
72 Terumo Cardiovascular Systems Corporation II Jan-29-2009
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