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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device subsystem, proportioning
Product CodeFKR
Regulation Number 876.5820
Device Class 2

MDR Year MDR Reports MDR Events
2019 3 3
2022 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Therapeutic or Diagnostic Output Failure 1 1
Priming Problem 1 1
Fire 1 1
Failure to Prime 1 1
Patient-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Numbness 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Low Blood Pressure/ Hypotension 2 2
Unspecified Infection 2 2
Dizziness 2 2
Urticaria 1 1
Discomfort 1 1
Reaction 1 1
Arrhythmia 1 1
Fatigue 1 1
Fever 1 1
Headache 1 1
Hypersensitivity/Allergic reaction 1 1
Itching Sensation 1 1
Pneumonia 1 1
Seizures 1 1
Tachycardia 1 1
Weakness 1 1
Burning Sensation 1 1
Tingling 1 1
Chills 1 1
Shaking/Tremors 1 1
Lethargy 1 1

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