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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
DEKA RESEARCH AND DEVELOPMENT
  SUBSTANTIALLY EQUIVALENT 1
DI-CHEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 7
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
2020 243 243
2021 63 63
2022 25 25
2023 59 59
2024 259 259
2025 77 77

Device Problems MDRs with this Device Problem Events in those MDRs
Chemical Problem 210 210
Leak/Splash 208 208
Break 205 205
Thermal Decomposition of Device 100 100
No Apparent Adverse Event 61 61
Smoking 60 60
Device Contaminated During Manufacture or Shipping 43 43
Adverse Event Without Identified Device or Use Problem 25 25
Melted 21 21
Sparking 18 18
Fluid/Blood Leak 9 9
Fire 7 7
Material Puncture/Hole 7 7
Arcing 5 5
Burst Container or Vessel 4 4
Product Quality Problem 4 4
Filtration Problem 3 3
Device Markings/Labelling Problem 2 2
Unintended Electrical Shock 2 2
Contamination 2 2
Material Rupture 2 2
Output Problem 1 1
Patient-Device Incompatibility 1 1
Fail-Safe Did Not Operate 1 1
Unsealed Device Packaging 1 1
Defective Component 1 1
Material Integrity Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Key or Button Unresponsive/not Working 1 1
Tear, Rip or Hole in Device Packaging 1 1
Display or Visual Feedback Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 411 411
No Patient Involvement 158 158
No Known Impact Or Consequence To Patient 69 69
Insufficient Information 24 24
Chemical Exposure 22 22
Death 11 11
Myocardial Infarction 6 6
Electrolyte Imbalance 5 5
No Code Available 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
Rash 2 2
Dyspnea 2 2
Bradycardia 2 2
Eye Injury 2 2
Eye Pain 2 2
Low Blood Pressure/ Hypotension 2 2
High Blood Pressure/ Hypertension 1 1
Hypersensitivity/Allergic reaction 1 1
Nausea 1 1
No Information 1 1
Dizziness 1 1
Skin Inflammation/ Irritation 1 1
Hematoma 1 1
Dry Eye(s) 1 1
Local Reaction 1 1
Burning Sensation 1 1
Swelling 1 1
Vomiting 1 1
Swelling/ Edema 1 1
Tachycardia 1 1
Blurred Vision 1 1
No Consequences Or Impact To Patient 1 1
Loss of consciousness 1 1
Hemorrhage/Bleeding 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Diasol, Inc II Oct-23-2024
2 Diasol, Inc II Jun-18-2020
3 Fresenius Medical Care Holdings, Inc. II Nov-04-2022
4 Fresenius Medical Care Holdings, Inc. II Jul-12-2022
5 Fresenius Medical Care Holdings, Inc. II Jul-01-2022
6 Fresenius Medical Care Holdings, Inc. II Jul-16-2021
7 Fresenius Medical Care Holdings, Inc. II Feb-01-2021
8 Fresenius Medical Care Holdings, Inc. II Jan-11-2021
9 Fresenius Medical Care Holdings, Inc. II Jan-11-2021
10 Isopure Corp II Sep-13-2022
11 Isopure Corp II Jan-19-2020
12 Nipro Renal Soultions USA, Corporation I May-14-2025
13 Nipro Renal Soultions USA, Corporation II Jan-08-2025
14 NxStage Medical Inc II May-28-2025
15 NxStage Medical Inc II Jun-20-2024
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