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	6
HAEMOPHARM BIOFLUIDS S.R.L.
	SUBSTANTIALLY EQUIVALENT	1
NIPRO RENAL SOLUTIONS USA, CORP.
	SUBSTANTIALLY EQUIVALENT	1
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
Break	223	223
Leak/Splash	219	219
Thermal Decomposition of Device	97	97
Fluid/Blood Leak	89	91
No Apparent Adverse Event	61	61
Smoking	57	57
Material Separation	48	48
Device Contaminated During Manufacture or Shipping	43	43
Detachment of Device or Device Component	33	33
Defective Component	29	29
Chemical Problem	20	20
Melted	17	17
Sparking	13	13
Fire	8	8
Adverse Event Without Identified Device or Use Problem	6	6
Arcing	6	6
Product Quality Problem	4	4
Output Problem	3	3
Filtration Problem	3	3
Unintended Electrical Shock	3	3
Crack	2	2
Device Markings/Labelling Problem	2	3
Burst Container or Vessel	2	2
Contamination	2	2
Device Contamination with Chemical or Other Material	2	2
Incomplete or Inadequate Connection	1	1
Material Puncture/Hole	1	1
Patient-Device Incompatibility	1	1
Fail-Safe Did Not Operate	1	1
Wrong Label	1	1
Defective Device	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Key or Button Unresponsive/not Working	1	1
Disconnection	1	1
Blocked Connection	1	1
Material Rupture	1	1
Appropriate Term/Code Not Available	1	1
Display or Visual Feedback Problem	1	1
Loose or Intermittent Connection	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	527	529
Insufficient Information	23	24
Chemical Exposure	22	22
No Patient Involvement	8	8
Electrolyte Imbalance	5	5
No Known Impact Or Consequence To Patient	3	3
Eye Injury	3	3
Eye Pain	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Corneal Abrasion	2	2
Rash	2	2
Burning Sensation	2	2
Vomiting	2	2
Bradycardia	2	2
Low Blood Pressure/ Hypotension	2	2
Non specific EKG/ECG Changes	1	1
High Blood Pressure/ Hypertension	1	1
Hypersensitivity/Allergic reaction	1	1
Nausea	1	1
Dizziness	1	1
Skin Inflammation/ Irritation	1	1
Dry Eye(s)	1	1
Hematoma	1	1
Itching Sensation	1	1
Local Reaction	1	1
Cardiac Arrest	1	1
Fever	1	1
Chills	1	1
Discomfort	1	1
Numbness	1	1
Dyspnea	1	1
Tachycardia	1	1
Swelling/ Edema	1	1
Blurred Vision	1	1
Headache	1	1
Hemorrhage/Bleeding	1	1
No Consequences Or Impact To Patient	1	1
Loss of consciousness	1	1
Hypervolemia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Diasol, Inc	II	Dec-23-2025
2	Diasol, Inc	II	Oct-23-2024
3	Fresenius Medical Care Holdings, Inc.	II	Jun-11-2026
4	Fresenius Medical Care Holdings, Inc.	II	Jun-05-2026
5	Fresenius Medical Care Holdings, Inc.	II	Nov-04-2022
6	Fresenius Medical Care Holdings, Inc.	II	Jul-12-2022
7	Fresenius Medical Care Holdings, Inc.	II	Jul-01-2022
8	Fresenius Medical Care Holdings, Inc.	II	Jul-16-2021
9	Fresenius Medical Care Holdings, Inc.	II	Feb-01-2021
10	Fresenius Medical Care Holdings, Inc.	II	Jan-11-2021
11	Fresenius Medical Care Holdings, Inc.	II	Jan-11-2021
12	Isopure Corp	II	Sep-13-2022
13	Nipro Renal Soultions USA, Corporation	I	May-14-2025
14	Nipro Renal Soultions USA, Corporation	II	Jan-08-2025
15	NxStage Medical Inc	II	May-28-2025
16	NxStage Medical Inc	II	Jun-20-2024