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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)
Product CodeKPO
Regulation Number 876.5820
Device Class 2


Premarket Reviews
ManufacturerDecision
BAXTER HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DI-CHEM, INC.
  SUBSTANTIALLY EQUIVALENT 2
DIMESOL USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 5
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

MDR Year MDR Reports MDR Events
2017 80 80
2018 97 97
2019 79 79
2020 243 243
2021 63 63
2022 15 15

Device Problems MDRs with this Device Problem Events in those MDRs
Chemical Problem 211 211
Adverse Event Without Identified Device or Use Problem 123 123
Thermal Decomposition of Device 92 92
Smoking 47 47
Melted 35 35
Fluid Leak 24 24
Material Rupture 16 16
Sparking 16 16
Fire 13 13
Material Puncture/Hole 11 11
Leak/Splash 9 9
Inadequate Ultra Filtration 6 6
Burst Container or Vessel 6 6
Break 5 5
Contamination 5 5
Product Quality Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Off-Label Use 3 3
Insufficient Information 3 3
Device Markings/Labelling Problem 3 3
Arcing 2 2
Use of Device Problem 2 2
Corroded 2 2
Component Falling 2 2
Overheating of Device 2 2
Unsealed Device Packaging 1 1
Particulates 1 1
Loss of Power 1 1
Inadequate Instructions for Healthcare Professional 1 1
Kinked 1 1
Crack 1 1
Electrical /Electronic Property Problem 1 1
Unintended Ejection 1 1
Partial Blockage 1 1
Detachment Of Device Component 1 1
Inappropriate/Inadequate Shock/Stimulation 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Loose or Intermittent Connection 1 1
Patient-Device Incompatibility 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Component Missing 1 1
Inadequate Filtration Process 1 1
Tear, Rip or Hole in Device Packaging 1 1
Filtration Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Material Integrity Problem 1 1
No Flow 1 1
Material Split, Cut or Torn 1 1
Unintended Electrical Shock 1 1
Fail-Safe Did Not Operate 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 248 248
No Known Impact Or Consequence To Patient 110 110
No Clinical Signs, Symptoms or Conditions 60 60
Death 48 48
Hemolysis 31 31
Cardiac Arrest 27 27
Insufficient Information 12 12
No Consequences Or Impact To Patient 12 12
Electrolyte Imbalance 9 9
Myocardial Infarction 8 8
Low Blood Pressure/ Hypotension 6 6
Loss of consciousness 6 6
No Code Available 6 6
Seizures 5 5
Cardiopulmonary Arrest 5 5
Dyspnea 4 4
Chest Pain 4 4
Nausea 4 4
No Information 4 4
Chemical Exposure 4 4
Respiratory Failure 4 4
Vomiting 4 4
Burning Sensation 4 4
Respiratory Distress 3 3
Arrhythmia 3 3
Angina 2 2
Apnea 2 2
Stroke/CVA 2 2
Bradycardia 2 2
Corneal Abrasion 2 2
Fever 2 2
Swelling 2 2
Chills 2 2
Cramp(s) 2 2
Sudden Cardiac Death 2 2
Diaphoresis 2 2
Blood Loss 1 1
Caustic/Chemical Burns 1 1
Confusion/ Disorientation 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Patient Problem/Medical Problem 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Ventricular Flutter 1 1
Itching Sensation 1 1
Liver Damage/Dysfunction 1 1
Increased Sensitivity 1 1
Sepsis 1 1
Septic Shock 1 1
Pain 1 1
Pneumonia 1 1
Renal Disease, End Stage 1 1
Hepatitis 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Pulmonary Embolism 1 1
Erythema 1 1
Fall 1 1
Burn(s) 1 1
Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diasol, Inc II Jun-18-2020
2 Fresenius Medical Care Holdings, Inc. II Jul-12-2022
3 Fresenius Medical Care Holdings, Inc. II Jul-01-2022
4 Fresenius Medical Care Holdings, Inc. II Jul-16-2021
5 Fresenius Medical Care Holdings, Inc. II Feb-01-2021
6 Fresenius Medical Care Holdings, Inc. II Jan-11-2021
7 Fresenius Medical Care Holdings, Inc. II Jan-11-2021
8 Fresenius Medical Care Renal Therapies Group, LLC III Nov-29-2018
9 Fresenius Medical Care Renal Therapies Group, LLC II Jun-07-2018
10 Fresenius Medical Care Renal Therapies Group, LLC II Mar-14-2018
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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