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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
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
DI-CHEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 6
HAEMOPHARM BIOFLUIDS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ISOPURE, CORP.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO RENAL SOLUTIONS USA, CORP.
  SUBSTANTIALLY EQUIVALENT 2
NXSTAGE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 79 79
2020 243 243
2021 63 63
2022 25 25
2023 59 59
2024 240 240

Device Problems MDRs with this Device Problem Events in those MDRs
Chemical Problem 210 210
Leak/Splash 189 189
Break 186 186
Thermal Decomposition of Device 101 101
Smoking 67 67
No Apparent Adverse Event 61 61
Adverse Event Without Identified Device or Use Problem 59 59
Melted 29 29
Sparking 20 20
Fluid/Blood Leak 18 18
Material Puncture/Hole 11 11
Fire 7 7
Arcing 5 5
Product Quality Problem 4 4
Filtration Problem 3 3
Inadequate Ultra Filtration 3 3
Burst Container or Vessel 3 3
Device Markings/Labelling Problem 2 2
Unintended Electrical Shock 2 2
Improper or Incorrect Procedure or Method 2 2
Material Rupture 2 2
Defective Component 1 1
Material Integrity Problem 1 1
Unsealed Device Packaging 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Contamination 1 1
Inadequate Instructions for Healthcare Professional 1 1
Contamination /Decontamination Problem 1 1
Key or Button Unresponsive/not Working 1 1
Display or Visual Feedback Problem 1 1
Inadequate Filtration Process 1 1
Output Problem 1 1
Fail-Safe Did Not Operate 1 1
Patient-Device Incompatibility 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 331 331
No Patient Involvement 184 184
No Known Impact Or Consequence To Patient 85 85
Hemolysis 28 28
Chemical Exposure 17 17
Insufficient Information 17 17
Death 12 12
Electrolyte Imbalance 9 9
Myocardial Infarction 6 6
No Consequences Or Impact To Patient 4 4
No Code Available 3 3
Low Blood Pressure/ Hypotension 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Corneal Abrasion 2 2
Itching Sensation 2 2
Cardiac Arrest 2 2
Dyspnea 2 2
Bradycardia 2 2
Eye Pain 2 2
High Blood Pressure/ Hypertension 1 1
Hypersensitivity/Allergic reaction 1 1
Seizures 1 1
Nausea 1 1
No Information 1 1
Dizziness 1 1
Skin Inflammation/ Irritation 1 1
Hematoma 1 1
Rash 1 1
Chest Pain 1 1
Swelling 1 1
Vomiting 1 1
Cardiopulmonary Arrest 1 1
Eye Injury 1 1
Swelling/ Edema 1 1
Blurred Vision 1 1
Loss of consciousness 1 1
Hemorrhage/Bleeding 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diasol, Inc II Jun-18-2020
2 Fresenius Medical Care Holdings, Inc. II Nov-04-2022
3 Fresenius Medical Care Holdings, Inc. II Jul-12-2022
4 Fresenius Medical Care Holdings, Inc. II Jul-01-2022
5 Fresenius Medical Care Holdings, Inc. II Jul-16-2021
6 Fresenius Medical Care Holdings, Inc. II Feb-01-2021
7 Fresenius Medical Care Holdings, Inc. II Jan-11-2021
8 Fresenius Medical Care Holdings, Inc. II Jan-11-2021
9 Isopure Corp II Sep-13-2022
10 Isopure Corp II Jan-19-2020
11 NxStage Medical Inc II Jun-20-2024
12 NxStage Medical, Inc. II Jun-02-2019
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