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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


Premarket Reviews
ManufacturerDecision
NXSTAGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 1 1
2017 2 2
2018 2 2
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 8 8
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
Low Blood Pressure/ Hypotension 3 3
Numbness 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Shaking/Tremors 2 2
Chills 2 2
Dizziness 2 2
Unspecified Infection 2 2
Death 2 2
Fever 2 2
Weakness 2 2
Burning Sensation 1 1
Tingling 1 1
Headache 1 1
Hypersensitivity/Allergic reaction 1 1
Fatigue 1 1
Arrhythmia 1 1
Bacterial Infection 1 1
Cardiac Arrest 1 1
Itching Sensation 1 1
Pneumonia 1 1
Respiratory Distress 1 1
Seizures 1 1
Sepsis 1 1
Tachycardia 1 1
Urticaria 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Reaction 1 1
Lethargy 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 NxStage Medical, Inc. II Mar-01-2018
2 NxStage Medical, Inc. II Jun-24-2014
3 NxStage Medical, Inc. III Jan-20-2012
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