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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
2017 2 2
2018 2 2
2019 3 3
2022 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5 5
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 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
No Clinical Signs, Symptoms or Conditions 3 3
Chills 2 2
Low Blood Pressure/ Hypotension 2 2
Unspecified Infection 2 2
Fever 2 2
Weakness 2 2
Numbness 2 2
Shaking/Tremors 2 2
Lethargy 1 1
No Code Available 1 1
Burning Sensation 1 1
Tingling 1 1
Headache 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Seizures 1 1
Sepsis 1 1
Tachycardia 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1
Death 1 1
Fatigue 1 1
Complaint, Ill-Defined 1 1
Reaction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 NxStage Medical, Inc. II Mar-01-2018
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