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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 1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 35 35
2021 42 42
2022 37 37
2023 41 41
2024 72 72
2025 125 153

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 119 119
Leak/Splash 64 64
Device Sensing Problem 31 31
Failure to Sense 25 53
Pumping Stopped 13 13
Electrical /Electronic Property Problem 8 8
False Negative Result 6 6
Incorrect Interpretation of Signal 6 6
Smoking 5 5
Unable to Obtain Readings 5 5
Thermal Decomposition of Device 5 5
Insufficient Information 4 4
Failure to Power Up 4 4
Incorrect Measurement 4 4
Fluid/Blood Leak 3 3
Intermittent Loss of Power 3 3
False Positive Result 3 3
Computer Software Problem 3 3
Insufficient Flow or Under Infusion 3 3
Failure to Pump 3 3
Operating System Becomes Nonfunctional 2 2
Protective Measures Problem 2 2
Fail-Safe Problem 2 2
Erratic or Intermittent Display 2 2
Premature Activation 1 1
Improper or Incorrect Procedure or Method 1 1
Gas Output Problem 1 1
Display or Visual Feedback Problem 1 1
Inappropriate or Unexpected Reset 1 1
High pH 1 1
Overheating of Device 1 1
Complete Loss of Power 1 1
Human-Device Interface Problem 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Under-Sensing 1 1
Increase in Pressure 1 1
Activation Failure 1 1
Electrical Shorting 1 1
Low Readings 1 1
Device Emits Odor 1 1
Calibration Problem 1 1
Misconnection 1 1
Use of Incorrect Control/Treatment Settings 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Decrease in Pressure 1 1
Excess Flow or Over-Infusion 1 1
Inaccurate Flow Rate 1 1
Decrease in Suction 1 1
Improper Flow or Infusion 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 304 332
No Consequences Or Impact To Patient 28 28
Insufficient Information 14 14
No Patient Involvement 7 7
No Known Impact Or Consequence To Patient 3 3
Hemorrhage/Bleeding 3 3
Air Embolism 2 2
Blood Loss 2 2
Death 1 1
No Information 1 1
Ischemia 1 1
Injury 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular Us Sales, Llc II Nov-12-2020
2 Terumo Cardiovascular Systems Corporation II Jun-24-2025
3 Terumo Cardiovascular Systems Corporation II Mar-31-2025
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