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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 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
2020 243 243
2021 63 63
2022 25 25
2023 59 59
2024 259 259
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Chemical Problem 210 210
Leak/Splash 195 195
Break 193 193
Thermal Decomposition of Device 96 96
No Apparent Adverse Event 61 61
Smoking 59 59
Adverse Event Without Identified Device or Use Problem 25 25
Melted 20 20
Sparking 18 18
Fluid/Blood Leak 9 9
Fire 7 7
Material Puncture/Hole 7 7
Arcing 5 5
Product Quality Problem 4 4
Filtration Problem 3 3
Burst Container or Vessel 3 3
Device Contaminated During Manufacture or Shipping 3 3
Device Markings/Labelling Problem 2 2
Unintended Electrical Shock 2 2
Material Rupture 2 2
Tear, Rip or Hole in Device Packaging 1 1
Display or Visual Feedback Problem 1 1
Unsealed Device Packaging 1 1
Key or Button Unresponsive/not Working 1 1
Material Integrity Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Patient-Device Incompatibility 1 1
Output Problem 1 1
Contamination 1 1
Fail-Safe Did Not Operate 1 1
Defective Component 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 354 354
No Patient Involvement 158 158
No Known Impact Or Consequence To Patient 69 69
Chemical Exposure 21 21
Insufficient Information 20 20
Death 11 11
Myocardial Infarction 6 6
Electrolyte Imbalance 5 5
No Code Available 3 3
Bradycardia 2 2
Cardiac Arrest 2 2
Corneal Abrasion 2 2
Dyspnea 2 2
Low Blood Pressure/ Hypotension 2 2
Itching Sensation 2 2
Rash 2 2
Eye Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Eye Injury 1 1
Headache 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Nausea 1 1
Local Reaction 1 1
Swelling 1 1
Tachycardia 1 1
Blurred Vision 1 1
Vomiting 1 1
Dizziness 1 1
No Consequences Or Impact To Patient 1 1
Loss of consciousness 1 1
No Information 1 1
Skin Inflammation/ Irritation 1 1
Swelling/ Edema 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 II Jan-08-2025
13 NxStage Medical Inc II Jun-20-2024
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