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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device monitor, blood-gas, on-line, cardiopulmonary bypass
Product CodeDRY
Regulation Number 870.4330
Device Class 2


Premarket Reviews
ManufacturerDecision
LIVANOVA DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CARDIOPULMONARY AG
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 5
SPECTRUM MEDICAL, LLP
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 156 156
2015 231 231
2016 240 240
2017 61 61
2018 165 165
2019 63 63
2020 35 35
2021 42 42
2022 37 37
2023 41 41
2024 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 332 332
Leak/Splash 295 295
Connection Problem 137 137
Incorrect Or Inadequate Test Results 88 88
Fluid/Blood Leak 38 38
Thermal Decomposition of Device 35 35
Device Operates Differently Than Expected 25 25
Nonstandard Device 23 23
Device Displays Incorrect Message 18 18
Incorrect Measurement 18 18
Smoking 18 18
Electrical /Electronic Property Problem 15 15
Failure to Power Up 12 12
High Readings 10 10
No Display/Image 6 6
Overheating of Device 5 5
Failure to Calibrate 5 5
Impedance Problem 5 5
Calibration Problem 4 4
High Test Results 4 4
Unable to Obtain Readings 4 4
Battery Problem 4 4
Insufficient Information 4 4
Invalid Sensing 4 4
Circuit Failure 3 3
Low Test Results 3 3
Improper Device Output 3 3
Out-Of-Box Failure 3 3
No Device Output 3 3
Pumping Stopped 3 3
Corroded 3 3
Device Inoperable 3 3
Electrical Overstress 3 3
Device Sensing Problem 3 3
Electrical Shorting 3 3
Low Readings 3 3
Crack 3 3
Charred 2 2
Failure to Run on Battery 2 2
Noise, Audible 2 2
Loose or Intermittent Connection 2 2
Display or Visual Feedback Problem 2 2
Device Emits Odor 2 2
Electrical Power Problem 2 2
Failure to Sense 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Alarm System 1 1
Gel Leak 1 1
Image Display Error/Artifact 1 1
Incorrect Interpretation of Signal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 379 379
No Patient Involvement 314 314
No Known Impact Or Consequence To Patient 142 142
No Clinical Signs, Symptoms or Conditions 140 140
Blood Loss 87 87
No Information 27 27
Insufficient Information 12 12
Not Applicable 9 9
Air Embolism 2 2
Death 2 2
Dysphasia 1 1
Ischemia 1 1
Injury 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular Us Sales, Llc II Nov-12-2020
2 Terumo Cardiovascular Systems Corporation II Aug-11-2018
3 Terumo Cardiovascular Systems Corporation III Oct-03-2016
4 Terumo Cardiovascular Systems Corporation II Mar-25-2016
5 Terumo Cardiovascular Systems Corporation II Sep-09-2015
6 Terumo Cardiovascular Systems Corporation II May-19-2014
7 Terumo Cardiovascular Systems Corporation II Jul-13-2013
8 Terumo Cardiovascular Systems Corporation II Feb-12-2013
9 Terumo Cardiovascular Systems Corporation II Apr-06-2012
10 Terumo Cardiovascular Systems Corporation II Jan-11-2012
11 Terumo Cardiovascular Systems Corporation II Jan-11-2012
12 Terumo Cardiovascular Systems Corporation II Oct-31-2011
13 Terumo Cardiovascular Systems Corporation II Jun-28-2011
14 Terumo Cardiovascular Systems Corporation II Jun-22-2011
15 Terumo Cardiovascular Systems Corporation II May-12-2011
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