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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filter, blood, cardiopulmonary bypass, arterial line
Product CodeDTM
Regulation Number 870.4260
Device Class 2


Premarket Reviews
ManufacturerDecision
TRANSMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 22 22
Fluid/Blood Leak 14 14
Crack 3 3
Device Operates Differently Than Expected 2 2
Particulates 2 2
Device Inoperable 1 1
Noise, Audible 1 1
Mechanical Problem 1 1
Break 1 1
Difficult to Fold, Unfold or Collapse 1 1
Insufficient Information 1 1
Contamination /Decontamination Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Fracture 1 1
Loose or Intermittent Connection 1 1
Restricted Flow rate 1 1
Occlusion Within Device 1 1
Improper Flow or Infusion 1 1
Connection Problem 1 1
Coagulation in Device or Device Ingredient 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 14 14
No Patient Involvement 10 10
No Clinical Signs, Symptoms or Conditions 8 8
No Information 7 7
No Consequences Or Impact To Patient 7 7
Blood Loss 2 2
Low Oxygen Saturation 2 2
Seizures 1 1
Brain Injury 1 1
Hyperglycemia 1 1
Thrombus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Perfusion Systems II Dec-17-2019
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