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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 827 827
2024 551 551

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 1046 1046
Output Problem 764 764
Device Operates Differently Than Expected 604 604
Pumping Stopped 491 491
Other (for use when an appropriate device code cannot be identified) 434 434
Device Alarm System 359 359
No Display/Image 322 322
Pumping Problem 308 308
Battery Problem 308 308
Display or Visual Feedback Problem 304 304
Failure to Calibrate 276 276
Mechanical Problem 215 215
Break 205 205
Difficult to Open or Close 195 195
Calibration Problem 193 193
Power Problem 184 184
Electrical /Electronic Property Problem 165 165
Incorrect, Inadequate or Imprecise Result or Readings 165 165
Charging Problem 140 140
Pressure Problem 134 134
Failure to Power Up 125 125
Infusion or Flow Problem 116 116
Communication or Transmission Problem 116 116
Device Sensing Problem 105 105
False Alarm 99 99
No Flow 96 96
Fluid/Blood Leak 94 94
Device Stops Intermittently 87 87
Leak/Splash 87 87
Appropriate Term/Code Not Available 85 85
Failure to Read Input Signal 77 77
Failure to Pump 75 75
Out-Of-Box Failure 75 75
Connection Problem 72 72
Device Inoperable 68 68
Inadequate User Interface 61 61
Adverse Event Without Identified Device or Use Problem 57 57
Loss of Power 57 57
Failure to Run on Battery 52 52
Mechanical Jam 51 51
Improper Flow or Infusion 49 49
Loose or Intermittent Connection 47 47
Insufficient Information 47 47
Noise, Audible 45 45
Erratic or Intermittent Display 44 44
Use of Device Problem 44 44
Inaccurate Flow Rate 42 42
Failure to Charge 40 40
Device Operational Issue 40 40
Unable to Obtain Readings 39 39

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2663 2663
No Consequences Or Impact To Patient 2574 2574
No Patient Involvement 1666 1666
No Known Impact Or Consequence To Patient 1111 1111
Insufficient Information 233 233
No Patient involvement 202 202
No Information 127 127
Not Applicable 126 126
Death 100 100
Cardiac Arrest 42 42
Air Embolism 16 16
Low Oxygen Saturation 13 13
Blood Loss 12 12
Low Blood Pressure/ Hypotension 9 9
Hemorrhage/Bleeding 9 9
Arrhythmia 8 8
Brain Injury 8 8
No Code Available 6 6
Hematuria 6 6
Exsanguination 5 5
Cardiopulmonary Arrest 5 5
Bronchial Hemorrhage 4 4
Asystole 4 4
Bone Fracture(s) 4 4
Neurological Deficit/Dysfunction 4 4
Bradycardia 3 3
Ischemia 3 3
Peroneal Nerve Palsy 3 3
Injury 3 3
Hemothorax 2 2
Airway Obstruction 2 2
Meningitis 2 2
Bacterial Infection 2 2
Hypoxia 2 2
Valvular Stenosis 2 2
Intracranial Hemorrhage 2 2
Burn(s) 2 2
Myocarditis 2 2
Multiple Organ Failure 2 2
Low Cardiac Output 2 2
Other (for use when an appropriate patient code cannot be identified) 2 2
Hematoma 2 2
Collagen disease 2 2
Respiratory Arrest 2 2
Sepsis 2 2
Respiratory Acidosis 1 1
Post Operative Wound Infection 1 1
Hemolytic Anemia 1 1
Convulsion, Tonic 1 1
Pallor 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 May-16-2024
11 Maquet Medical Systems USA II Feb-08-2024
12 Maquet Medical Systems USA II Dec-21-2023
13 Maquet Medical Systems USA II Dec-14-2023
14 Maquet Medical Systems USA I Dec-07-2023
15 Maquet Medical Systems USA II Nov-09-2023
16 Maquet Medical Systems USA II May-26-2023
17 Maquet Medical Systems USA II Apr-08-2022
18 Maquet Medical Systems USA II Oct-25-2013
19 Salyer Prn Biomedical II Mar-01-2013
20 Sorin Group Deutschland GmbH II Jan-28-2014
21 Sorin Group Deutschland GmbH II Nov-04-2013
22 Sorin Group Deutschland GmbH II Mar-29-2012
23 Sorin Group USA, Inc. II Sep-21-2016
24 Sorin Group USA, Inc. II Nov-08-2012
25 Sorin Group USA, Inc. II Mar-05-2012
26 Sorin Group USA, Inc. II Jan-26-2011
27 Sorin Group USA, Inc. II Jul-22-2010
28 Spectrum Medical Ltd. I Aug-23-2019
29 Terumo Cardiovascular Systems Corporation II Aug-26-2021
30 Terumo Cardiovascular Systems Corporation II Sep-12-2020
31 Terumo Cardiovascular Systems Corporation II Feb-07-2020
32 Terumo Cardiovascular Systems Corporation II Jun-11-2019
33 Terumo Cardiovascular Systems Corporation II May-15-2019
34 Terumo Cardiovascular Systems Corporation II Oct-18-2018
35 Terumo Cardiovascular Systems Corporation II Sep-25-2018
36 Terumo Cardiovascular Systems Corporation II Apr-20-2018
37 Terumo Cardiovascular Systems Corporation II Mar-14-2017
38 Terumo Cardiovascular Systems Corporation II May-28-2015
39 Terumo Cardiovascular Systems Corporation II Jul-08-2014
40 Terumo Cardiovascular Systems Corporation II Aug-15-2013
41 Terumo Cardiovascular Systems Corporation II Aug-14-2013
42 Terumo Cardiovascular Systems Corporation II Aug-14-2013
43 Terumo Cardiovascular Systems Corporation II Nov-27-2012
44 Terumo Cardiovascular Systems Corporation II Nov-13-2012
45 Terumo Cardiovascular Systems Corporation II Oct-24-2012
46 Terumo Cardiovascular Systems Corporation II Sep-25-2012
47 Terumo Cardiovascular Systems Corporation II Sep-24-2012
48 Terumo Cardiovascular Systems Corporation II Sep-11-2012
49 Terumo Cardiovascular Systems Corporation II Aug-21-2012
50 Terumo Cardiovascular Systems Corporation III Aug-16-2012
51 Terumo Cardiovascular Systems Corporation II Aug-09-2012
52 Terumo Cardiovascular Systems Corporation II Jul-20-2012
53 Terumo Cardiovascular Systems Corporation II Jul-19-2012
54 Terumo Cardiovascular Systems Corporation II Jul-17-2012
55 Terumo Cardiovascular Systems Corporation II Jul-13-2012
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-09-2012
60 Terumo Cardiovascular Systems Corporation II Jul-06-2012
61 Terumo Cardiovascular Systems Corporation II Apr-23-2012
62 Terumo Cardiovascular Systems Corporation II Mar-27-2012
63 Terumo Cardiovascular Systems Corporation II Jan-24-2012
64 Terumo Cardiovascular Systems Corporation II Nov-29-2011
65 Terumo Cardiovascular Systems Corporation II Nov-29-2011
66 Terumo Cardiovascular Systems Corporation II Jul-06-2011
67 Terumo Cardiovascular Systems Corporation II Jun-22-2011
68 Terumo Cardiovascular Systems Corporation II Mar-07-2011
69 Terumo Cardiovascular Systems Corporation II Jan-07-2011
70 Terumo Cardiovascular Systems Corporation II Sep-23-2010
71 Terumo Cardiovascular Systems Corporation II May-29-2009
72 Terumo Cardiovascular Systems Corporation II Feb-24-2009
73 Terumo Cardiovascular Systems Corporation II Jan-29-2009
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