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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
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 28 28

Device Problems MDRs with this Device Problem Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings 128 128
Leak/Splash 67 67
Smoking 5 5
Failure to Power Up 5 5
Thermal Decomposition of Device 5 5
Electrical /Electronic Property Problem 5 5
Insufficient Information 3 3
Pumping Stopped 3 3
Unable to Obtain Readings 3 3
Incorrect Measurement 3 3
Failure to Sense 2 2
Electrical Overstress 2 2
Disconnection 1 1
Sparking 1 1
False Negative Result 1 1
Crack 1 1
Image Display Error/Artifact 1 1
Electrical Power Problem 1 1
Failure to Recalibrate 1 1
Degraded 1 1
Gas/Air Leak 1 1
Decrease in Pressure 1 1
Use of Incorrect Control/Treatment Settings 1 1
Calibration Problem 1 1
Device Sensing Problem 1 1
Electrical Shorting 1 1
Computer Software Problem 1 1
Under-Sensing 1 1
Failure to Calibrate 1 1
Gel Leak 1 1
Incorrect Interpretation of Signal 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
Fluid/Blood Leak 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 140 140
No Consequences Or Impact To Patient 58 58
No Patient Involvement 32 32
Insufficient Information 12 12
No Known Impact Or Consequence To Patient 6 6
Blood Loss 5 5
No Information 4 4
Air Embolism 2 2
Death 1 1
Ischemia 1 1
Injury 1 1

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