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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
SORIN GROUP ITALIA S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
TRANSMEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 5 5
2020 1 1
2021 1 1
2022 4 4
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 4 4
Crack 3 3
Fluid/Blood Leak 3 3
Mechanical Problem 1 1
Material Puncture/Hole 1 1
Insufficient Information 1 1
Contamination 1 1
Contamination /Decontamination Problem 1 1
Improper Flow or Infusion 1 1
Device Contamination with Chemical or Other Material 1 1
Coagulation in Device or Device Ingredient 1 1
Connection Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
No Information 2 2
No Consequences Or Impact To Patient 2 2
Seizures 1 1
Brain Injury 1 1
Low Oxygen Saturation 1 1

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