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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device filter, blood, cardiopulmonary bypass, arterial line
Product CodeDTM
Regulation Number 870.4260
Device Class 2


Premarket Reviews
ManufacturerDecision
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MAQUET CARDIOPULMONARY AG
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC PERFUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
PAREXELINTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TRANSMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 64 64
2015 34 34
2016 27 27
2017 15 15
2018 23 23
2019 5 5
2020 1 1
2021 1 1
2022 4 4
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 78 78
Fluid/Blood Leak 51 51
Device Contamination with Chemical or Other Material 16 16
Particulates 14 14
Device Operates Differently Than Expected 11 11
Crack 6 6
Other (for use when an appropriate device code cannot be identified) 5 5
Break 4 4
Occlusion Within Device 4 4
Out-Of-Box Failure 3 3
Infusion or Flow Problem 3 3
Improper Flow or Infusion 2 2
Pressure Problem 2 2
Filtration Problem 2 2
Device Damaged Prior to Use 2 2
Complete Blockage 2 2
Fracture 2 2
Mechanical Problem 1 1
Use of Device Problem 1 1
Restricted Flow rate 1 1
Difficult to Fold, Unfold or Collapse 1 1
Insufficient Information 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Expiration Issue 1 1
Contamination /Decontamination Problem 1 1
Contamination 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Failure to Prime 1 1
Contamination of Device Ingredient or Reagent 1 1
Partial Blockage 1 1
Free or Unrestricted Flow 1 1
Connection Problem 1 1
Coagulation in Device or Device Ingredient 1 1
Component(s), broken 1 1
Loose or Intermittent Connection 1 1
Device Handling Problem 1 1
Increase in Pressure 1 1
Device Inoperable 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 65 65
No Patient Involvement 63 63
No Consequences Or Impact To Patient 14 14
No Information 12 12
No Clinical Signs, Symptoms or Conditions 8 8
No Patient involvement 5 5
Blood Loss 3 3
Thrombus 3 3
Low Oxygen Saturation 2 2
Seizures 1 1
Brain Injury 1 1
Rupture 1 1
Hyperglycemia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. Cardiac Rhythm Disease Management II Aug-14-2013
2 Medtronic Perfusion Systems II Dec-17-2019
3 Terumo Cardiovascular Systems Corporation II Sep-20-2013
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