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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device transducer, blood-pressure, extravascular
Regulation Description Extravascular blood pressure transducer.
Product CodeDRS
Regulation Number 870.2850
Device Class 2


Premarket Reviews
ManufacturerDecision
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 41 41
2021 93 93
2022 95 95
2023 148 148
2024 205 205
2025 98 98

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 136 136
Material Separation 130 130
Disconnection 66 66
Break 56 56
Incorrect, Inadequate or Imprecise Result or Readings 39 39
Separation Failure 28 28
No Flow 24 24
Crack 24 24
Air/Gas in Device 24 24
Separation Problem 23 23
Inaccurate Information 21 21
Incorrect Measurement 18 18
Detachment of Device or Device Component 16 16
Unable to Obtain Readings 14 14
Leak/Splash 12 12
Pressure Problem 12 12
High Readings 11 11
Material Split, Cut or Torn 8 8
Material Integrity Problem 6 6
Reflux within Device 5 5
Device Markings/Labelling Problem 5 5
Device Sensing Problem 5 5
Output Problem 4 4
Connection Problem 4 4
Device Contamination with Chemical or Other Material 4 4
Obstruction of Flow 4 4
Failure to Zero 4 4
Backflow 4 4
Electrical /Electronic Property Problem 3 3
Infusion or Flow Problem 3 3
Gas/Air Leak 3 3
Difficult to Insert 3 3
Mechanical Problem 3 3
Inappropriate Waveform 3 3
Difficult to Flush 3 3
Loss of or Failure to Bond 2 2
Contamination 2 2
Defective Device 2 2
Fail-Safe Problem 2 2
Deformation Due to Compressive Stress 2 2
Improper Flow or Infusion 2 2
Loose or Intermittent Connection 2 2
Calibration Problem 2 2
Material Puncture/Hole 2 2
Low Readings 2 2
Display Difficult to Read 2 2
Incomplete or Inadequate Connection 2 2
Inaccurate Delivery 2 2
Failure to Calibrate 2 2
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 579 579
Hemorrhage/Bleeding 38 38
Insufficient Information 23 23
No Consequences Or Impact To Patient 20 20
No Known Impact Or Consequence To Patient 8 8
No Patient Involvement 8 8
Blood Loss 6 6
Death 3 3
Low Blood Pressure/ Hypotension 3 3
Thrombosis/Thrombus 2 2
Discomfort 2 2
Air Embolism 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cardiac Arrest 1 1
Burn(s) 1 1
Vomiting 1 1
Extravasation 1 1
Blurred Vision 1 1
Respiratory Insufficiency 1 1
Headache 1 1
Loss of Vision 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC II Nov-29-2023
2 MEDLINE INDUSTRIES, LP - Northfield II Mar-21-2025
3 Smiths Medical ASD Inc. II Apr-21-2021
4 Smiths Medical Asd Inc II Jan-17-2024
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