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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 87 87

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 117 117
Leak/Splash 66 66
Device Sensing Problem 55 55
Failure to Sense 33 61
Pumping Stopped 19 19
Incorrect Measurement 8 8
Electrical /Electronic Property Problem 8 8
Incorrect Interpretation of Signal 7 7
False Negative Result 6 6
Insufficient Device Problem Information 6 6
Fluid/Blood Leak 5 5
Thermal Decomposition of Device 5 5
Unable to Obtain Readings 5 5
Failure to Pump 4 4
Output Problem 4 4
Computer Software Problem 4 4
Smoking 4 4
Insufficient Flow or Under Infusion 3 3
Failure to Power Up 3 3
Over-Sensing 3 3
Decreased Pump Speed 3 3
Pumping Problem 3 3
False Positive Result 3 3
Intermittent Loss of Power 3 3
Operating System Becomes Nonfunctional 3 3
Complete Loss of Power 2 2
Protective Measures Problem 2 2
Fail-Safe Problem 2 2
Application Program Freezes or Fails to Launch 2 2
Erratic or Intermittent Display 2 2
Electrical Shorting 2 2
Human-Device Interface Problem 1 1
Connection Problem 1 1
Overheating of Device 1 1
Under-Sensing 1 1
Increase in Pressure 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
Activation Failure 1 1
Low Readings 1 1
No Device Output 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
Infusion or Flow Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 394 422
Insufficient Information 19 19
Hemorrhage/Blood Loss/Bleeding 3 3
No Consequences Or Impact To Patient 3 3
Air Embolism 2 2
Intraoperative Cardiac Valve Injury 1 1
Ischemia 1 1
Low Oxygen Saturation 1 1
Reduced Blood Flow 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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