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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
SPECTRUM MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 4
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 61 61
2018 165 165
2019 63 63
2020 35 35
2021 42 42
2022 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 175 175
Incorrect, Inadequate or Imprecise Resultor Readings 132 132
Thermal Decomposition of Device 16 16
Incorrect Measurement 13 13
Electrical /Electronic Property Problem 12 12
Smoking 11 11
Failure to Power Up 5 5
Connection Problem 5 5
Device Operates Differently Than Expected 4 4
Device Displays Incorrect Message 4 4
Improper Device Output 3 3
Calibration Problem 2 2
Electrical Overstress 2 2
Invalid Sensing 2 2
Out-Of-Box Failure 2 2
Failure to Calibrate 2 2
Overheating of Device 2 2
No Display/Image 2 2
Fluid Leak 2 2
Gel Leak 1 1
Image Display Error/Artifact 1 1
Corroded 1 1
Crack 1 1
Degraded 1 1
Display or Visual Feedback Problem 1 1
Decrease in Pressure 1 1
Unable to Obtain Readings 1 1
Device Inoperable 1 1
High Readings 1 1
Low Readings 1 1
High pH 1 1
Electrical Shorting 1 1
Gas Leak 1 1
Sparking 1 1
Battery Problem 1 1
Insufficient Information 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 155 155
No Consequences Or Impact To Patient 121 121
No Clinical Signs, Symptoms or Conditions 73 73
Blood Loss 33 33
No Known Impact Or Consequence To Patient 13 13
No Information 9 9
Insufficient Information 4 4
Death 1 1
Injury 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
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