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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
DIMESOL USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 4
GLOBAL SCIENTIFIC TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
HAEMOPHARM BIOFLUIDS S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ISOPURE, CORP.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO RENAL SOLUTIONS USA, CORP.
  SUBSTANTIALLY EQUIVALENT 2
RENAL CARE DIALYSIS SOLUTIONS, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 97 97
2019 79 79
2020 243 243
2021 63 63
2022 25 25
2023 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
Chemical Problem 211 211
Thermal Decomposition of Device 96 96
Adverse Event Without Identified Device or Use Problem 78 78
Smoking 64 64
Melted 33 33
Fluid/Blood Leak 24 24
Sparking 22 22
Material Rupture 16 16
Material Puncture/Hole 11 11
Leak/Splash 10 10
Fire 7 7
Inadequate Ultra Filtration 6 6
Burst Container or Vessel 6 6
Break 6 6
Contamination 6 6
Product Quality Problem 4 4
Improper or Incorrect Procedure or Method 4 4
Insufficient Information 3 3
Arcing 3 3
Use of Device Problem 2 2
Patient-Device Incompatibility 2 2
Device Markings/Labelling Problem 2 2
Component Falling 2 2
Detachment Of Device Component 1 1
Corroded 1 1
Display or Visual Feedback Problem 1 1
Unintended Ejection 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Unsealed Device Packaging 1 1
Off-Label Use 1 1
Loose or Intermittent Connection 1 1
Inadequate Instructions for Healthcare Professional 1 1
Filtration Problem 1 1
Material Integrity Problem 1 1
Output Problem 1 1
Contamination /Decontamination Problem 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1
Component Missing 1 1
Inadequate Filtration Process 1 1
Tear, Rip or Hole in Device Packaging 1 1
Material Split, Cut or Torn 1 1
Unintended Electrical Shock 1 1
Fail-Safe Did Not Operate 1 1
Key or Button Unresponsive/not Working 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 219 219
No Known Impact Or Consequence To Patient 106 106
No Clinical Signs, Symptoms or Conditions 101 101
Hemolysis 31 31
Death 17 17
Insufficient Information 13 13
No Consequences Or Impact To Patient 11 11
Electrolyte Imbalance 9 9
Myocardial Infarction 6 6
Cardiac Arrest 6 6
Low Blood Pressure/ Hypotension 5 5
Dyspnea 4 4
Nausea 4 4
Vomiting 4 4
Burning Sensation 4 4
Chemical Exposure 4 4
No Information 4 4
No Code Available 4 4
Chest Pain 3 3
Corneal Abrasion 2 2
Itching Sensation 2 2
Cardiopulmonary Arrest 2 2
Bradycardia 2 2
Cramp(s) 2 2
Swelling 2 2
Respiratory Distress 2 2
Loss of consciousness 2 2
Respiratory Failure 2 2
Caustic/Chemical Burns 1 1
Diaphoresis 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Seizures 1 1
Increased Sensitivity 1 1
Sepsis 1 1
Pain 1 1
Rash 1 1
Bacterial Infection 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Dizziness 1 1
Burn(s) 1 1
Erythema 1 1
Fall 1 1
Liver Damage/Dysfunction 1 1
Hemorrhage/Bleeding 1 1
Hepatitis 1 1
Hypersensitivity/Allergic reaction 1 1
High Blood Pressure/ Hypertension 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 Fresenius Medical Care Renal Therapies Group, LLC III Nov-29-2018
10 Fresenius Medical Care Renal Therapies Group, LLC II Jun-07-2018
11 Fresenius Medical Care Renal Therapies Group, LLC II Mar-14-2018
12 Isopure Corp II Sep-13-2022
13 Isopure Corp II Jan-19-2020
14 NxStage Medical, Inc. II Jun-02-2019
15 NxStage Medical, Inc. II Nov-27-2018
16 NxStage Medical, Inc. II Mar-19-2018
17 Rockwell Medical, Inc II May-14-2018
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