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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
  1.  K202154  B-Capta
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 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 187 187
Incorrect, Inadequate or Imprecise Resultor Readings 177 177
Connection Problem 124 124
Thermal Decomposition of Device 23 23
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
Out-Of-Box Failure 3 3
Improper Device Output 3 3
Battery Problem 3 3
Calibration Problem 2 2
Electrical Overstress 2 2
No Display/Image 2 2
Low Readings 2 2
Failure to Calibrate 2 2
Overheating of Device 2 2
Failure to Run on Battery 1 1
Calibration Error 1 1
Corroded 1 1
Crack 1 1
Degraded 1 1
Device Issue 1 1
High pH 1 1
Unable to Obtain Readings 1 1
Gel Leak 1 1
High Readings 1 1
Device Inoperable 1 1
Sparking 1 1
Electrical Shorting 1 1
Gas Leak 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Temperature Problem 1 1
Noise, Audible 1 1
Complete Loss of Power 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 37 37
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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