• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
BELLCO SRL
  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
2015 8338 8338
2016 240 240
2017 80 80
2018 97 97
2019 79 79
2020 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 8238 8238
Adverse Event Without Identified Device or Use Problem 314 314
Thermal Decomposition of Device 76 76
Fluid Leak 58 58
Smoking 41 41
Bag 32 32
Melted 28 28
Leak/Splash 26 26
Fire 16 16
Device Operates Differently Than Expected 16 16
Material Rupture 14 14
Microbial Contamination of Device 13 13
Sparking 13 13
Appropriate Term/Code Not Available 12 12
Patient-Device Incompatibility 11 11
Manufacturing, Packaging or Shipping Problem 10 10
Material Puncture/Hole 9 9
Nonstandard Device 7 7
Burst Container or Vessel 6 6
Inadequate Ultra Filtration 6 6
Improper or Incorrect Procedure or Method 5 5
Contamination 5 5
Mechanical Problem 5 5
Break 5 5
Overheating of Device 3 3
Use of Device Problem 3 3
Off-Label Use 3 3
Device Contamination with Chemical or Other Material 3 3
Improper Chemical Reaction 2 2
Calibration Problem 2 2
Device Displays Incorrect Message 2 2
Particulates 2 2
Component Falling 2 2
Corroded 2 2
Crack 2 2
Material Discolored 2 2
Cap 2 2
Seal 2 2
Spring Loading Mechanism 2 2
No Apparent Adverse Event 2 2
Material Split, Cut or Torn 1 1
Connector 1 1
Port 1 1
Tube 1 1
Housing 1 1
Device Alarm System 1 1
Partial Blockage 1 1
Electrical /Electronic Property Problem 1 1
Unintended Ejection 1 1
Charred 1 1
Detachment Of Device Component 1 1
Loose or Intermittent Connection 1 1
Imprecision 1 1
Labelling, Instructions for Use or Training Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Kinked 1 1
Loss of Power 1 1
Unsealed Device Packaging 1 1
Component Missing 1 1
Inadequate Filtration Process 1 1
Tear, Rip or Hole in Device Packaging 1 1
Insufficient Flow or Under Infusion 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
Chemical Problem 1 1
Contamination /Decontamination Problem 1 1
Device Markings/Labelling Problem 1 1
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1
Failure of Device to Self-Test 1 1
Improper Device Output 1 1
No Flow 1 1
Packaging Problem 1 1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 1 1
Needle 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 7265 7265
Cardiac Arrest 4646 4646
No Code Available 1709 1709
Cardiopulmonary Arrest 601 601
Myocardial Infarction 580 580
Arrhythmia 349 349
Sudden Cardiac Death 294 294
Injury 200 200
No Patient Involvement 191 191
Stroke/CVA 111 111
Low Blood Pressure/ Hypotension 76 76
No Known Impact Or Consequence To Patient 59 59
Loss of consciousness 36 36
Hemolysis 32 32
Ventricular Tachycardia 31 31
Sepsis 31 31
Respiratory Failure 28 28
Ventricular Fibrillation 23 23
Heart Failure 23 23
Encephalopathy 20 20
Cramp(s) 19 19
Atrial Fibrillation 18 18
Chest Pain 17 17
Nausea 17 17
Congestive Heart Failure 17 17
Dyspnea 16 16
No Consequences Or Impact To Patient 15 15
Vomiting 15 15
No Information 15 15
Brain Injury 14 14
Seizures 14 14
Bradycardia 13 13
Unspecified Infection 13 13
Fever 12 12
Electrolyte Imbalance 11 11
Bacterial Infection 10 10
Tachycardia 9 9
Syncope 8 8
Septic Shock 8 8
Hypersensitivity/Allergic reaction 8 8
Chills 7 7
Aspiration/Inhalation 6 6
Pulmonary Edema 6 6
Headache 6 6
Complaint, Ill-Defined 6 6
Chemical Exposure 5 5
Respiratory Distress 5 5
Anemia 5 5
Renal Disease, End Stage 5 5
Cardiomyopathy 5 5
Ischemic Heart Disease 4 4
Collapse 4 4
High Blood Pressure/ Hypertension 4 4
Hemorrhage, Cerebral 4 4
Pleural Effusion 4 4
Death, Intrauterine Fetal 4 4
Apnea 4 4
Blood Loss 4 4
Hypervolemia 4 4
Anxiety 4 4
Diabetic Ketoacidosis 4 4
Burning Sensation 4 4
Discomfort 3 3
Cardiogenic Shock 3 3
Anoxia 3 3
Diarrhea 3 3
Itching Sensation 3 3
Pneumonia 3 3
Corneal Perforation 3 3
Pulmonary Embolism 3 3
Renal Failure 3 3
Transient Ischemic Attack 2 2
Ischemia 2 2
Swelling 2 2
Abscess 2 2
Aortic Valve Stenosis 2 2
Corneal Abrasion 2 2
Non specific EKG/ECG Changes 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Multiple Organ Failure 2 2
Diaphoresis 2 2
Numbness 2 2
Pain 2 2
Urinary Tract Infection 2 2
Hypoglycemia 2 2
Hypoxia 2 2
Deafness 2 2
Edema 2 2
Infarction, Cerebral 2 2
Amputation 2 2
Angina 2 2
Disability 2 2
Seizures, Absence 2 2
Alteration In Body Temperature 2 2
Shaking/Tremors 2 2
Loss Of Pulse 2 2
Confusion/ Disorientation 1 1
Weight Changes 1 1
Patient Problem/Medical Problem 1 1
Hot Flashes/Flushes 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 Aug-12-2015
4 Fresenius Medical Care Holdings, Inc. II Jun-22-2015
5 Fresenius Medical Care Renal Therapies Group, LLC III Nov-29-2018
6 Fresenius Medical Care Renal Therapies Group, LLC II Jun-07-2018
7 Fresenius Medical Care Renal Therapies Group, LLC II Mar-14-2018
8 Fresenius Medical Care Renal Therapies Group, LLC II Feb-25-2016
9 Fresenius Medical Care Renal Therapies Group, LLC II Nov-18-2015
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
-
-