Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 5
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 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Chemical Problem 210 210
Thermal Decomposition of Device 90 90
Smoking 65 65
Adverse Event Without Identified Device or Use Problem 59 59
Melted 29 29
Sparking 20 20
Fluid/Blood Leak 18 18
Leak/Splash 13 13
Material Puncture/Hole 11 11
Break 10 10
Fire 7 7
Arcing 5 5
No Apparent Adverse Event 5 5
Product Quality Problem 4 4
Inadequate Ultra Filtration 3 3
Burst Container or Vessel 3 3
Filtration Problem 3 3
Unintended Electrical Shock 2 2
Device Markings/Labelling Problem 2 2
Material Rupture 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Component 1 1
Component Missing 1 1
Inadequate Filtration Process 1 1
Tear, Rip or Hole in Device Packaging 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Unsealed Device Packaging 1 1
Contamination 1 1
Display or Visual Feedback Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Fail-Safe Did Not Operate 1 1
Key or Button Unresponsive/not Working 1 1
Material Integrity Problem 1 1
Output Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 184 184
No Clinical Signs, Symptoms or Conditions 139 139
No Known Impact Or Consequence To Patient 85 85
Hemolysis 28 28
Insufficient Information 13 13
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
Itching Sensation 2 2
Dyspnea 2 2
Bradycardia 2 2
Cardiac Arrest 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Loss of consciousness 1 1
No Information 1 1
Cardiopulmonary Arrest 1 1
Chest Pain 1 1
Hemorrhage/Bleeding 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 1 1
Rash 1 1
Seizures 1 1
Swelling 1 1
Vomiting 1 1
Dizziness 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
-
-