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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
2019 63 63
2020 35 35
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 166 166
Leak/Splash 92 92
Device Sensing Problem 46 46
Failure to Sense 32 60
Pumping Stopped 19 19
Incorrect Measurement 10 10
Electrical /Electronic Property Problem 9 9
Smoking 7 7
Incorrect Interpretation of Signal 7 7
False Negative Result 6 6
Fluid/Blood Leak 5 5
Insufficient Information 5 5
Thermal Decomposition of Device 5 5
Unable to Obtain Readings 5 5
Failure to Power Up 5 5
Output Problem 4 4
Computer Software Problem 4 4
Intermittent Loss of Power 3 3
Failure to Pump 3 3
False Positive Result 3 3
Insufficient Flow or Under Infusion 3 3
Pumping Problem 3 3
Calibration Problem 2 2
Operating System Becomes Nonfunctional 2 2
Electrical Shorting 2 2
Decreased Pump Speed 2 2
Erratic or Intermittent Display 2 2
Electrical Overstress 2 2
Over-Sensing 2 2
Application Program Freezes, Becomes Nonfunctional 2 2
Protective Measures Problem 2 2
Fail-Safe Problem 2 2
Low Readings 1 1
Activation Failure 1 1
Increase in Pressure 1 1
Under-Sensing 1 1
Failure to Calibrate 1 1
Gel Leak 1 1
Connection Problem 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
No Device Output 1 1
Premature Activation 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 378 406
No Consequences Or Impact To Patient 58 58
No Patient Involvement 32 32
Insufficient Information 18 18
No Known Impact Or Consequence To Patient 6 6
Blood Loss 5 5
No Information 4 4
Hemorrhage/Bleeding 3 3
Air Embolism 2 2
Death 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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