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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 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 111 111
Leak/Splash 63 63
Device Sensing Problem 46 46
Failure to Sense 32 60
Pumping Stopped 19 19
Incorrect Measurement 8 8
Electrical /Electronic Property Problem 7 7
Incorrect Interpretation of Signal 7 7
False Negative Result 6 6
Fluid/Blood Leak 5 5
Thermal Decomposition of Device 5 5
Unable to Obtain Readings 5 5
Insufficient Information 5 5
Computer Software Problem 4 4
Output Problem 4 4
Smoking 4 4
Failure to Pump 3 3
Insufficient Flow or Under Infusion 3 3
Failure to Power Up 3 3
Pumping Problem 3 3
False Positive Result 3 3
Intermittent Loss of Power 3 3
Decreased Pump Speed 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Protective Measures Problem 2 2
Fail-Safe Problem 2 2
Over-Sensing 2 2
Erratic or Intermittent Display 2 2
Electrical Shorting 2 2
Operating System Becomes Nonfunctional 2 2
Calibration Problem 2 2
Human-Device Interface Problem 1 1
Complete Loss of Power 1 1
Connection Problem 1 1
Overheating of Device 1 1
Inappropriate or Unexpected Reset 1 1
Under-Sensing 1 1
Display or Visual Feedback Problem 1 1
Increase in Pressure 1 1
Gas Output Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Activation Failure 1 1
No Device Output 1 1
Low Readings 1 1
Device Emits Odor 1 1
Premature Activation 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 370 398
Insufficient Information 18 18
Hemorrhage/Bleeding 3 3
No Consequences Or Impact To Patient 3 3
Air Embolism 2 2
Ischemia 1 1
Low Oxygen Saturation 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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