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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dialysate concentrate for hemodialysis (liquid or powder)
Regulation Description Hemodialysis system and accessories.
Product CodeKPO
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DI-CHEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE NORTH AMERICA
  SUBSTANTIALLY EQUIVALENT 4
ROCKWELL MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 240 240
2017 80 80
2018 97 97
2019 79 79
2020 243 243
2021 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Chemical Problem 201 201
Adverse Event Without Identified Device or Use Problem 187 187
Insufficient Information 124 124
Thermal Decomposition of Device 81 81
Smoking 43 43
Melted 28 28
Leak/Splash 25 25
Fluid Leak 17 17
Sparking 15 15
Material Rupture 15 15
Fire 13 13
Material Puncture/Hole 10 10
Nonstandard Device 7 7
Burst Container or Vessel 6 6
Inadequate Ultra Filtration 6 6
Improper or Incorrect Procedure or Method 5 5
Bag 5 5
Contamination 5 5
Microbial Contamination of Device 5 5
Device Operates Differently Than Expected 5 5
Use of Device Problem 3 3
Overheating of Device 3 3
Off-Label Use 3 3
Mechanical Problem 2 2
Cap 2 2
Break 2 2
Crack 2 2
Appropriate Term/Code Not Available 2 2
Corroded 2 2
Device Markings/Labelling Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Component Falling 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Improper Chemical Reaction 1 1
Electrical Shorting 1 1
Failure of Device to Self-Test 1 1
Contamination /Decontamination Problem 1 1
Electrical /Electronic Property Problem 1 1
Imprecision 1 1
Kinked 1 1
Partial Blockage 1 1
Detachment Of Device Component 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Inadequate Filtration Process 1 1
Tear, Rip or Hole in Device Packaging 1 1
Arcing 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Loose or Intermittent Connection 1 1
Material Split, Cut or Torn 1 1
Filtration Problem 1 1
No Flow 1 1
Packaging Problem 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Component Missing 1 1
Patient-Device Incompatibility 1 1
Calibration Problem 1 1
Unintended Ejection 1 1
Seal 1 1
Tube 1 1
Charred 1 1
Inadequate Instructions for Healthcare Professional 1 1
Unsealed Device Packaging 1 1
Particulates 1 1
Loss of Power 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 283 283
Death 177 177
Cardiac Arrest 126 126
No Known Impact Or Consequence To Patient 112 112
Hemolysis 31 31
Cardiopulmonary Arrest 25 25
No Code Available 23 23
No Consequences Or Impact To Patient 16 16
Loss of consciousness 12 12
Myocardial Infarction 12 12
Chest Pain 10 10
Syncope 8 8
Seizures 8 8
Dyspnea 8 8
Sepsis 8 8
Low Blood Pressure/ Hypotension 7 7
Respiratory Failure 6 6
Nausea 6 6
Vomiting 5 5
Electrolyte Imbalance 5 5
No Information 5 5
Respiratory Distress 4 4
Burning Sensation 4 4
Chemical Exposure 4 4
Blood Loss 4 4
Arrhythmia 4 4
Bradycardia 4 4
Sudden Cardiac Death 4 4
Insufficient Information 4 4
Chills 3 3
Fever 3 3
Corneal Abrasion 2 2
Cramp(s) 2 2
Septic Shock 2 2
Swelling 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Diaphoresis 2 2
Numbness 2 2
Stroke/CVA 2 2
Atrial Fibrillation 2 2
Angina 2 2
Apnea 2 2
Hypoglycemia 2 2
Unspecified Infection 2 2
Itching Sensation 2 2
Hypervolemia 2 2
Headache 2 2
Brain Injury 2 2
Complaint, Ill-Defined 1 1
Injury 1 1
Confusion/ Disorientation 1 1
Diarrhea 1 1
Edema 1 1
Alteration In Body Temperature 1 1
Patient Problem/Medical Problem 1 1
Liver Damage/Dysfunction 1 1
Pain 1 1
Pneumonia 1 1
Bacterial Infection 1 1
Caustic/Chemical Burns 1 1
Ventricular Flutter 1 1
Renal Disease, End Stage 1 1
Increased Sensitivity 1 1
Pulmonary Embolism 1 1
Anemia 1 1
Burn(s) 1 1
Hepatitis 1 1
Hypersensitivity/Allergic reaction 1 1
Erythema 1 1
Fall 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corp. II Jun-24-2016
2 Diasol, Inc II Jun-18-2020
3 Fresenius Medical Care Holdings, Inc. II Feb-01-2021
4 Fresenius Medical Care Holdings, Inc. II Jan-11-2021
5 Fresenius Medical Care Holdings, Inc. II Jan-11-2021
6 Fresenius Medical Care Renal Therapies Group, LLC III Nov-29-2018
7 Fresenius Medical Care Renal Therapies Group, LLC II Jun-07-2018
8 Fresenius Medical Care Renal Therapies Group, LLC II Mar-14-2018
9 Fresenius Medical Care Renal Therapies Group, LLC II Feb-25-2016
10 Isopure Corp II Jan-19-2020
11 NxStage Medical, Inc. II Jun-02-2019
12 NxStage Medical, Inc. II Nov-27-2018
13 NxStage Medical, Inc. II Mar-19-2018
14 Rockwell Medical, Inc II May-14-2018
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