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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 CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DI-CHEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIMESOL USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 4
GLOBAL SCIENTIFIC TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
HAEMOPHARM BIOFLUIDS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ISOPURE, CORP.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO RENAL SOLUTIONS USA, CORP.
  SUBSTANTIALLY EQUIVALENT 1
ROCKWELL MEDICAL
  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 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Chemical Problem 211 211
Adverse Event Without Identified Device or Use Problem 187 187
Insufficient Information 124 124
Thermal Decomposition of Device 92 92
Smoking 47 47
Melted 32 32
Leak/Splash 27 27
Fluid Leak 22 22
Material Rupture 16 16
Fire 15 15
Sparking 15 15
Material Puncture/Hole 10 10
Nonstandard Device 7 7
Inadequate Ultra Filtration 6 6
Burst Container or Vessel 6 6
Contamination 5 5
Improper or Incorrect Procedure or Method 5 5
Microbial Contamination of Device 5 5
Device Operates Differently Than Expected 5 5
Product Quality Problem 4 4
Break 4 4
Use of Device Problem 3 3
Overheating of Device 3 3
Off-Label Use 3 3
Mechanical Problem 2 2
Component Falling 2 2
Corroded 2 2
Crack 2 2
Arcing 2 2
Device Markings/Labelling Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Appropriate Term/Code Not Available 2 2
Manufacturing, Packaging or Shipping Problem 2 2
No Flow 1 1
Packaging Problem 1 1
Material Split, Cut or Torn 1 1
Unintended Electrical Shock 1 1
Fail-Safe Did Not Operate 1 1
Improper Chemical Reaction 1 1
Electrical Shorting 1 1
Failure of Device to Self-Test 1 1
Filtration Problem 1 1
Component Missing 1 1
Inadequate Filtration Process 1 1
Tear, Rip or Hole in Device Packaging 1 1
Patient-Device Incompatibility 1 1
Calibration Problem 1 1
Contamination /Decontamination Problem 1 1
Electrical /Electronic Property Problem 1 1
Unintended Ejection 1 1
Charred 1 1
Detachment Of Device Component 1 1
Partial Blockage 1 1
Imprecision 1 1
Inadequate Instructions for Healthcare Professional 1 1
Kinked 1 1
Loose or Intermittent Connection 1 1
Unsealed Device Packaging 1 1
Particulates 1 1
Loss of Power 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Inappropriate/Inadequate Shock/Stimulation 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
No Clinical Signs, Symptoms or Conditions 42 42
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
Electrolyte Imbalance 9 9
Seizures 8 8
Sepsis 8 8
Insufficient Information 8 8
Dyspnea 8 8
Syncope 8 8
Low Blood Pressure/ Hypotension 7 7
Nausea 6 6
Respiratory Failure 6 6
No Information 5 5
Vomiting 5 5
Burning Sensation 4 4
Respiratory Distress 4 4
Sudden Cardiac Death 4 4
Chemical Exposure 4 4
Blood Loss 4 4
Arrhythmia 4 4
Bradycardia 4 4
Fever 3 3
Chills 3 3
Cramp(s) 2 2
Septic Shock 2 2
Swelling 2 2
Brain Injury 2 2
Diaphoresis 2 2
Hypervolemia 2 2
Headache 2 2
Hypoglycemia 2 2
Unspecified Infection 2 2
Itching Sensation 2 2
Atrial Fibrillation 2 2
Angina 2 2
Apnea 2 2
Corneal Abrasion 2 2
Stroke/CVA 2 2
Numbness 2 2
Edema 1 1
Erythema 1 1
Fall 1 1
Anemia 1 1
Bacterial Infection 1 1
Burn(s) 1 1
Liver Damage/Dysfunction 1 1
Pain 1 1
Pneumonia 1 1
Renal Disease, End Stage 1 1
Pulmonary Embolism 1 1
Hepatitis 1 1
Hypersensitivity/Allergic reaction 1 1
Diarrhea 1 1
Alteration In Body Temperature 1 1
Patient Problem/Medical Problem 1 1
Caustic/Chemical Burns 1 1
Confusion/ Disorientation 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Increased Sensitivity 1 1
Ventricular Flutter 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 Jul-16-2021
4 Fresenius Medical Care Holdings, Inc. II Feb-01-2021
5 Fresenius Medical Care Holdings, Inc. II Jan-11-2021
6 Fresenius Medical Care Holdings, Inc. II Jan-11-2021
7 Fresenius Medical Care Renal Therapies Group, LLC III Nov-29-2018
8 Fresenius Medical Care Renal Therapies Group, LLC II Jun-07-2018
9 Fresenius Medical Care Renal Therapies Group, LLC II Mar-14-2018
10 Fresenius Medical Care Renal Therapies Group, LLC II Feb-25-2016
11 Isopure Corp II Jan-19-2020
12 NxStage Medical, Inc. II Jun-02-2019
13 NxStage Medical, Inc. II Nov-27-2018
14 NxStage Medical, Inc. II Mar-19-2018
15 Rockwell Medical, Inc II May-14-2018
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