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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dialyzer, capillary, hollow fiber
Product CodeFJI
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 20 20
2020 16 16
2021 12 12
2022 2 2
2023 51 51
2024 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 146 146
Adverse Event Without Identified Device or Use Problem 7 7
Break 5 5
Crack 4 4
Device Contamination with Chemical or Other Material 3 3
Leak/Splash 1 1
Material Rupture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 111 111
No Known Impact Or Consequence To Patient 34 34
Hypersensitivity/Allergic reaction 6 6
Erythema 2 2
Fever 2 2
Hemorrhage/Bleeding 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Malaise 2 2
Blood Loss 1 1
No Patient Involvement 1 1
Muscle Hypotonia 1 1
Swelling/ Edema 1 1
Insufficient Information 1 1
Hiccups 1 1
Abdominal Pain 1 1
Anemia 1 1
Pyrosis/Heartburn 1 1
Hemolysis 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Itching Sensation 1 1
Nausea 1 1
Rash 1 1
Tachycardia 1 1
Vomiting 1 1

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