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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
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 42 42
2022 37 37
2023 41 41
2024 72 72
2025 139 167
2026 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 102 102
Leak/Splash 60 60
Device Sensing Problem 40 40
Failure to Sense 25 53
Pumping Stopped 16 16
Electrical /Electronic Property Problem 7 7
False Negative Result 6 6
Incorrect Interpretation of Signal 6 6
Thermal Decomposition of Device 5 5
Unable to Obtain Readings 5 5
Incorrect Measurement 4 4
Computer Software Problem 4 4
Smoking 4 4
Insufficient Information 4 4
False Positive Result 3 3
Output Problem 3 3
Failure to Power Up 3 3
Intermittent Loss of Power 3 3
Fluid/Blood Leak 3 3
Insufficient Flow or Under Infusion 3 3
Failure to Pump 3 3
Pumping Problem 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Protective Measures Problem 2 2
Fail-Safe Problem 2 2
Erratic or Intermittent Display 2 2
Operating System Becomes Nonfunctional 2 2
Inappropriate or Unexpected Reset 1 1
Overheating of Device 1 1
Complete Loss of Power 1 1
Human-Device Interface Problem 1 1
Connection Problem 1 1
Display or Visual Feedback Problem 1 1
Gas Output Problem 1 1
Under-Sensing 1 1
Improper or Incorrect Procedure or Method 1 1
Increase in Pressure 1 1
Activation Failure 1 1
Electrical Shorting 1 1
Low Readings 1 1
Device Emits Odor 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 327 355
Insufficient Information 14 14
Hemorrhage/Bleeding 3 3
No Consequences Or Impact To Patient 3 3
Air Embolism 2 2
Low Oxygen Saturation 1 1
Ischemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Terumo Cardiovascular Systems Corporation II Jun-24-2025
2 Terumo Cardiovascular Systems Corporation II Mar-31-2025
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