TPLC - Total Product Life Cycle

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Device	dialyzer, capillary, hollow fiber
Product Code	FJI
Regulation Number	876.5820
Device Class	2

Premarket Reviews
Manufacturer	Decision
FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC
	SUBSTANTIALLY EQUIVALENT	1
NIPRO MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	1637	1637
Adverse Event Without Identified Device or Use Problem	446	446
Crack	27	27
Insufficient Information	23	23
Material Rupture	15	15
Occlusion Within Device	14	14
Leak/Splash	10	10
Break	10	10
Device Contamination with Chemical or Other Material	6	6
Device Issue	5	5
Device Displays Incorrect Message	4	4
Filtration Problem	2	2
Loose or Intermittent Connection	2	2
Appropriate Term/Code Not Available	1	1
Device Contamination with Body Fluid	1	1
Burst Container or Vessel	1	1
Complete Blockage	1	1
Patient-Device Incompatibility	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Use of Device Problem	1	1
Infusion or Flow Problem	1	1
Device Handling Problem	1	1
Material Separation	1	1
Device Alarm System	1	1
Connection Problem	1	1
Improper Chemical Reaction	1	1
No Flow	1	1
Hole In Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	1475	1475
Itching Sensation	201	201
Reaction	172	172
No Clinical Signs, Symptoms or Conditions	155	155
Hypersensitivity/Allergic reaction	101	101
Death	50	50
Low Blood Pressure/ Hypotension	31	31
Blood Loss	29	29
Loss of consciousness	28	28
Cardiac Arrest	26	26
Nausea	20	20
Cardiopulmonary Arrest	19	19
Dyspnea	18	18
Seizures	18	18
Vomiting	11	11
Fever	10	10
Syncope	9	9
Anxiety	9	9
High Blood Pressure/ Hypertension	8	8
Hemorrhage/Bleeding	8	8
Myocardial Infarction	7	7
Bradycardia	6	6
Erythema	6	6
Chest Pain	6	6
No Code Available	6	6
Tachycardia	6	6
Rash	4	4
Loss Of Pulse	4	4
Thromboembolism	4	4
Anemia	4	4
Dizziness	4	4
Respiratory Distress	4	4
Arrhythmia	4	4
Pulmonary Embolism	4	4
Burning Sensation	3	3
Shaking/Tremors	3	3
Hypervolemia	3	3
First Use Syndrome	3	3
Edema	2	2
Malaise	2	2
Bacterial Infection	2	2
Hypoxia	2	2
No Consequences Or Impact To Patient	2	2
Anaphylactic Shock	2	2
Respiratory Failure	2	2
Diaphoresis	2	2
Sepsis	2	2
Low Oxygen Saturation	2	2
Renal Failure	2	2
Increased Sensitivity	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Fresenius Medical Care Renal Therapies Group, LLC	II	Apr-05-2016