TPLC - Total Product Life Cycle

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Device	dialyzer, capillary, hollow fiber
Regulation Description	Hemodialysis system and accessories.
Product Code	FJI
Regulation Number	876.5820
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	311	326
Adverse Event Without Identified Device or Use Problem	74	74
Break	34	35
Device Contamination with Chemical or Other Material	26	26
Crack	18	18
Compatibility Problem	3	3
Leak/Splash	2	2
Fracture	1	1
Material Rupture	1	1
Contamination	1	1
Air/Gas in Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	337	352
Hypersensitivity/Allergic reaction	65	65
Dyspnea	28	28
Low Blood Pressure/ Hypotension	20	20
Nausea	11	11
Itching Sensation	11	11
Hemorrhage/Blood Loss/Bleeding	10	10
Discomfort	10	10
Diaphoresis	10	10
Vomiting	8	8
Chest Pain	7	7
Tachycardia	6	6
Cough	6	6
Abdominal Pain	5	5
Dizziness	4	4
Fatigue	3	3
Swelling/ Edema	3	3
Chills	3	3
Rash	3	3
Hot Flashes/Flushes	3	3
Low Oxygen Saturation	3	3
Fever	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Wheezing	2	2
High Blood Pressure/ Hypertension	2	2
Erythema	2	2
Sore Throat	1	1
Syncope/Fainting	1	1
Shock	1	1
Cardiac Arrest	1	1
Cramp(s) /Muscle Spasm(s)	1	1
Skin Inflammation/ Irritation	1	1
Muscle Hypotonia	1	1
Heartburn/Indigestion	1	1
Anxiety	1	1
Hemolysis	1	1
Pallor	1	1
Asthma	1	1
Hiccups	1	1
Hyperglycemia	1	1
Cyanosis	1	1
Insufficient Information	1	1
Angioedema	1	1
Headache	1	1
Malaise	1	1
Numbness	1	1
Anemia	1	1
Abdominal Distention	1	1
Urinary Incontinence	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Fresenius Medical Care Holdings, Inc.	II	Oct-03-2025