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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

MDR Year MDR Reports MDR Events
2017 15 15
2018 23 23
2019 5 5
2020 1 1
2021 1 1
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Leak/Splash 22 22
Fluid Leak 14 14
Device Operates Differently Than Expected 2 2
Particulates 2 2
Device Inoperable 1 1
Contamination /Decontamination Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Improper Flow or Infusion 1 1
Insufficient Information 1 1
Noise, Audible 1 1
Difficult to Fold, Unfold or Collapse 1 1
Fracture 1 1
Loose or Intermittent Connection 1 1
Occlusion Within Device 1 1
Break 1 1
Coagulation in Device or Device Ingredient 1 1
Crack 1 1
Restricted Flow rate 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 Information 7 7
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 4 4
Low Oxygen Saturation 2 2
Blood Loss 2 2
Brain Injury 1 1
Hyperglycemia 1 1
Seizures 1 1
Thrombus 1 1

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