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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 16 44

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 106 106
Leak/Splash 54 54
Failure to Sense 10 38
Pumping Stopped 9 9
Device Sensing Problem 7 7
False Negative Result 6 6
Thermal Decomposition of Device 5 5
Failure to Power Up 4 4
Insufficient Information 4 4
Electrical /Electronic Property Problem 4 4
Smoking 4 4
Unable to Obtain Readings 3 3
Incorrect Measurement 3 3
Incorrect Interpretation of Signal 2 2
Fail-Safe Problem 2 2
Electrical Shorting 1 1
Overheating of Device 1 1
Unexpected Shutdown 1 1
Complete Loss of Power 1 1
Fail-Safe Did Not Operate 1 1
Increased Pump Speed 1 1
Use of Incorrect Control/Treatment Settings 1 1
Inappropriate or Unexpected Reset 1 1
Low Readings 1 1
Use of Device Problem 1 1
Under-Sensing 1 1
Disconnection 1 1
Misconnection 1 1
Calibration Problem 1 1
Operating System Becomes Nonfunctional 1 1
Application Program Freezes, Becomes Nonfunctional 1 1
High pH 1 1
Fluid/Blood Leak 1 1
Sparking 1 1
Activation Failure 1 1
Decrease in Pressure 1 1
Failure to Pump 1 1
False Positive Result 1 1
Decrease in Suction 1 1
Image Display Error/Artifact 1 1
Crack 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Interrogate 1 1
Display or Visual Feedback Problem 1 1
Computer Software Problem 1 1
Degraded 1 1
Electrical Power Problem 1 1
Failure to Recalibrate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 196 224
No Consequences Or Impact To Patient 28 28
Insufficient Information 13 13
No Patient Involvement 7 7
No Known Impact Or Consequence To Patient 3 3
Hemorrhage/Bleeding 2 2
Blood Loss 2 2
Air Embolism 2 2
Injury 1 1
Death 1 1
Ischemia 1 1
No Information 1 1
Low Oxygen Saturation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Maquet Cardiovascular Us Sales, Llc II Nov-12-2020
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