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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
Regulation Description Cardiopulmonary bypass on-line blood gas monitor.
Product CodeDRY
Regulation Number 870.4330
Device Class 2


Premarket Reviews
ManufacturerDecision
LIVANOVA DEUTSCHLAND GMBH
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 4
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 240 240
2017 61 61
2018 165 165
2019 63 63
2020 35 35
2021 25 25

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 186 186
Incorrect, Inadequate or Imprecise Resultor Readings 173 173
Connection Problem 124 124
Thermal Decomposition of Device 22 22
Incorrect Measurement 15 15
Smoking 13 13
Electrical /Electronic Property Problem 12 12
Fluid Leak 11 11
Failure to Power Up 6 6
Device Operates Differently Than Expected 6 6
Device Displays Incorrect Message 5 5
Invalid Sensing 4 4
Battery Problem 3 3
Improper Device Output 3 3
Out-Of-Box Failure 3 3
Electrical Overstress 2 2
No Display/Image 2 2
Overheating of Device 2 2
Failure to Calibrate 2 2
Calibration Problem 2 2
Low Readings 2 2
Adverse Event Without Identified Device or Use Problem 1 1
Complete Loss of Power 1 1
Electrical Shorting 1 1
High pH 1 1
High Readings 1 1
Calibration Error 1 1
Corroded 1 1
Failure to Run on Battery 1 1
Unable to Obtain Readings 1 1
Device Inoperable 1 1
Sparking 1 1
Gel Leak 1 1
Crack 1 1
Degraded 1 1
Gas Leak 1 1
Temperature Problem 1 1
Noise, Audible 1 1
Device Issue 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 223 223
No Consequences Or Impact To Patient 197 197
No Known Impact Or Consequence To Patient 82 82
Blood Loss 50 50
No Clinical Signs, Symptoms or Conditions 31 31
No Information 19 19
Death 1 1
Injury 1 1
Insufficient Information 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
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