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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 139 167

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 121 121
Leak/Splash 66 66
Device Sensing Problem 38 38
Failure to Sense 25 53
Pumping Stopped 15 15
Electrical /Electronic Property Problem 8 8
False Negative Result 6 6
Incorrect Interpretation of Signal 6 6
Smoking 5 5
Thermal Decomposition of Device 5 5
Unable to Obtain Readings 5 5
Incorrect Measurement 4 4
Insufficient Information 4 4
Failure to Power Up 4 4
Fluid/Blood Leak 3 3
Intermittent Loss of Power 3 3
Failure to Pump 3 3
False Positive Result 3 3
Insufficient Flow or Under Infusion 3 3
Computer Software Problem 3 3
Operating System Becomes Nonfunctional 2 2
Pumping Problem 2 2
Protective Measures Problem 2 2
Erratic or Intermittent Display 2 2
Fail-Safe Problem 2 2
Device Emits Odor 1 1
Low Readings 1 1
Electrical Shorting 1 1
Activation Failure 1 1
Increase in Pressure 1 1
Under-Sensing 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
Human-Device Interface Problem 1 1
Complete Loss of Power 1 1
Overheating of Device 1 1
High pH 1 1
Inappropriate or Unexpected Reset 1 1
Display or Visual Feedback Problem 1 1
Gas Output Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Premature Activation 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 318 346
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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