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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
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 113 113

Device Problems MDRs with this Device Problem Events in those MDRs
Chemical Problem 210 210
Leak/Splash 99 99
Break 96 96
Thermal Decomposition of Device 95 95
Smoking 65 65
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
Inadequate Ultra Filtration 3 3
Burst Container or Vessel 3 3
Filtration Problem 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
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Defective Component 1 1
Component Missing 1 1
Inadequate Filtration Process 1 1
Tear, Rip or Hole in Device Packaging 1 1
Contamination 1 1
Display or Visual Feedback Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Unsealed Device Packaging 1 1
Fail-Safe Did Not Operate 1 1
Key or Button Unresponsive/not Working 1 1
Output Problem 1 1
Material Integrity Problem 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 231 231
No Patient Involvement 184 184
No Known Impact Or Consequence To Patient 85 85
Hemolysis 28 28
Insufficient Information 14 14
Death 12 12
Electrolyte Imbalance 9 9
Myocardial Infarction 6 6
No Consequences Or Impact To Patient 4 4
Low Blood Pressure/ Hypotension 3 3
No Code Available 3 3
Eye Pain 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Itching Sensation 2 2
Dyspnea 2 2
Bradycardia 2 2
Cardiac Arrest 2 2
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Headache 1 1
Hematoma 1 1
Nausea 1 1
Rash 1 1
Seizures 1 1
Swelling 1 1
Blurred Vision 1 1
Vomiting 1 1
Dizziness 1 1
Loss of consciousness 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Swelling/ Edema 1 1
No Information 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-02-2019
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