TPLC - Total Product Life Cycle

show TPLC since

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	8
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
Leak/Splash	213	213
Chemical Problem	210	210
Break	210	210
Thermal Decomposition of Device	106	106
No Apparent Adverse Event	61	61
Smoking	60	60
Device Contaminated During Manufacture or Shipping	43	43
Adverse Event Without Identified Device or Use Problem	27	27
Melted	22	22
Sparking	18	18
Fluid/Blood Leak	10	15
Fire	8	8
Material Puncture/Hole	8	56
Arcing	6	6
Burst Container or Vessel	4	4
Product Quality Problem	4	4
Filtration Problem	3	3
Unintended Electrical Shock	3	3
Device Markings/Labelling Problem	2	3
Contamination	2	2
Material Rupture	2	2
Output Problem	1	1
Patient-Device Incompatibility	1	1
Fail-Safe Did Not Operate	1	1
Defective Component	1	20
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
Inadequate Instructions for Healthcare Professional	1	2
Key or Button Unresponsive/not Working	1	1
Tear, Rip or Hole in Device Packaging	1	1
Device Contamination with Chemical or Other Material	1	1
Display or Visual Feedback Problem	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	424	426
No Patient Involvement	158	158
No Known Impact Or Consequence To Patient	70	119
Insufficient Information	24	25
Chemical Exposure	22	22
Death	11	11
Myocardial Infarction	6	6
Electrolyte Imbalance	5	5
Eye Pain	3	3
Eye Injury	3	3
No Code Available	3	3
Low Blood Pressure/ Hypotension	2	2
Bradycardia	2	2
Dyspnea	2	2
Vomiting	2	2
Burning Sensation	2	2
Rash	2	2
Cardiac Arrest	2	2
Itching Sensation	2	2
Corneal Abrasion	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Local Reaction	1	1
Fever	1	1
Hematoma	1	1
Dry Eye(s)	1	1
Chills	1	1
Swelling	1	1
Skin Inflammation/ Irritation	1	1
Discomfort	1	1
Numbness	1	1
No Information	1	1
Dizziness	1	1
Nausea	1	1
Hypersensitivity/Allergic reaction	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
High Blood Pressure/ Hypertension	1	1
Non specific EKG/ECG Changes	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