TPLC - Total Product Life Cycle

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Device	dialysate concentrate for hemodialysis (liquid or powder)
Regulation Description	Hemodialysis system and accessories.
Product Code	KPO
Regulation Number	876.5820
Device Class	2

Premarket Reviews
Manufacturer	Decision
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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Chemical Problem	210	210
Leak/Splash	207	207
Break	204	204
Thermal Decomposition of Device	100	100
No Apparent Adverse Event	61	61
Smoking	60	60
Adverse Event Without Identified Device or Use Problem	25	25
Melted	21	21
Sparking	18	18
Device Contaminated During Manufacture or Shipping	16	16
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
Contamination	2	2
Unintended Electrical Shock	2	2
Material Rupture	2	2
Patient-Device Incompatibility	1	1
Display or Visual Feedback Problem	1	1
Material Integrity Problem	1	1
Output Problem	1	1
Fail-Safe Did Not Operate	1	1
Key or Button Unresponsive/not Working	1	1
Inadequate Instructions for Healthcare Professional	1	1
Unsealed Device Packaging	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Component	1	1
Tear, Rip or Hole in Device Packaging	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	384	384
No Patient Involvement	158	158
No Known Impact Or Consequence To Patient	69	69
Insufficient Information	23	23
Chemical Exposure	22	22
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
Eye Injury	2	2
Low Blood Pressure/ Hypotension	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Itching Sensation	2	2
Rash	2	2
Eye Pain	2	2
Loss of consciousness	1	1
Dry Eye(s)	1	1
Headache	1	1
Hematoma	1	1
Hemorrhage/Bleeding	1	1
Hypersensitivity/Allergic reaction	1	1
High Blood Pressure/ Hypertension	1	1
Skin Inflammation/ Irritation	1	1
Swelling/ Edema	1	1
Nausea	1	1
Local Reaction	1	1
Swelling	1	1
Tachycardia	1	1
Blurred Vision	1	1
Vomiting	1	1
Burning Sensation	1	1
Dizziness	1	1
No Consequences Or Impact To Patient	1	1
No Information	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