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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accessories, blood circuit, hemodialysis
Product CodeKOC
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
FRESENIUS MEDICAL CARE
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 4
FRESENIUS MEDICAL CARE-NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIONS FOR ACCESS, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIKKISO CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
NIKKISO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 165 165
2015 555 555
2016 10 10
2017 23 23
2018 37 37
2019 56 56
2020 20 20
2021 33 33
2022 26 26
2023 16 16
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 770 770
Disconnection 48 48
Adverse Event Without Identified Device or Use Problem 35 35
Thermal Decomposition of Device 26 26
Leak/Splash 17 17
Smoking 16 16
Nonstandard Device 13 13
Crack 10 10
Loose or Intermittent Connection 7 7
Overheating of Device 7 7
Patient Device Interaction Problem 7 7
Fire 6 6
Connection Problem 5 5
Improper or Incorrect Procedure or Method 4 4
Melted 3 3
Detachment Of Device Component 3 3
Detachment of Device or Device Component 3 3
Device Emits Odor 3 3
Improper Flow or Infusion 2 2
Infusion or Flow Problem 2 2
Break 2 2
Air Leak 2 2
Component Missing 2 2
Inadequate Ultra Filtration 2 2
Device Displays Incorrect Message 2 2
Insufficient Heating 2 2
Occlusion Within Device 1 1
Material Puncture/Hole 1 1
Material Rupture 1 1
Device Slipped 1 1
Sparking 1 1
Cut In Material 1 1
Structural Problem 1 1
Failure to Advance 1 1
Device Alarm System 1 1
Failure To Adhere Or Bond 1 1
Charred 1 1
Coagulation in Device or Device Ingredient 1 1
Computer Software Problem 1 1
Misassembled 1 1
Misconnection 1 1
Restricted Flow rate 1 1
Display or Visual Feedback Problem 1 1
Material Twisted/Bent 1 1
Device-Device Incompatibility 1 1
Temperature Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Insufficient Information 1 1
Noise, Audible 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 768 768
No Clinical Signs, Symptoms or Conditions 55 55
Blood Loss 25 25
Hemorrhage/Bleeding 16 16
No Consequences Or Impact To Patient 15 15
Hemolysis 14 14
Low Blood Pressure/ Hypotension 13 13
No Patient Involvement 11 11
Reaction 8 8
Genital Bleeding 7 7
Death 5 5
Cardiac Arrest 4 4
Dyspnea 3 3
Hypothermia 3 3
Loss of consciousness 3 3
Needle Stick/Puncture 3 3
Insufficient Information 3 3
Dizziness 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Respiratory Failure 2 2
Burn, Thermal 2 2
Hypovolemia 2 2
Chills 2 2
Cramp(s) 2 2
Partial thickness (Second Degree) Burn 2 2
No Information 2 2
Anemia 2 2
Cardiopulmonary Arrest 2 2
Syncope 2 2
Abdominal Pain 1 1
Achalasia 1 1
Erythema 1 1
Exsanguination 1 1
High Blood Pressure/ Hypertension 1 1
Rash 1 1
Weakness 1 1
Renal Impairment 1 1
Vaso-Vagal Response 1 1
Patient Problem/Medical Problem 1 1
Cardiogenic Shock 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Fresenius Medical Care Holdings, Inc. II Jun-05-2015
2 Fresenius Medical Care Holdings, Inc. II Feb-03-2015
3 Fresenius Medical Care North America II Jan-23-2009
4 Fresenius Medical Care Renal Therapies Group, LLC II Jun-21-2016
5 Molded Products Inc II Mar-24-2017
6 Molded Products Inc II Mar-18-2013
7 Stihler Electronic Gmbh II Jan-23-2019
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