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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 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 63 63
2020 35 35
2021 42 42
2022 37 37
2023 41 41
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 122 122
Leak/Splash 62 62
Failure to Power Up 5 5
Smoking 5 5
Thermal Decomposition of Device 5 5
Electrical /Electronic Property Problem 4 4
Unable to Obtain Readings 3 3
Insufficient Information 3 3
Electrical Overstress 2 2
Incorrect Measurement 2 2
Overheating of Device 1 1
Decrease in Pressure 1 1
High pH 1 1
Failure to Calibrate 1 1
Sparking 1 1
Calibration Problem 1 1
Fluid/Blood Leak 1 1
Gel Leak 1 1
Image Display Error/Artifact 1 1
Crack 1 1
Degraded 1 1
Disconnection 1 1
Display or Visual Feedback Problem 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Gas/Air Leak 1 1
Inappropriate or Unexpected Reset 1 1
Complete Loss of Power 1 1
Failure to Recalibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 122 122
No Consequences Or Impact To Patient 58 58
No Patient Involvement 32 32
Insufficient Information 11 11
No Known Impact Or Consequence To Patient 6 6
Blood Loss 5 5
No Information 4 4
Air Embolism 2 2
Death 1 1
Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular Us Sales, Llc II Nov-12-2020
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