TPLC - Total Product Life Cycle

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Device	separator, automated, blood cell and plasma, therapeutic
Product Code	LKN
Device Class	Unclassified

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	377	415
Adverse Event Without Identified Device or Use Problem	351	430
No Apparent Adverse Event	75	77
Use of Device Problem	15	18
Patient-Device Incompatibility	11	17
Improper or Incorrect Procedure or Method	10	12
Inadequate User Interface	6	6
Output Problem	5	5
Fluid/Blood Leak	5	8
Device Handling Problem	5	7
Device Slipped	4	4
Mechanical Problem	4	4
Defective Device	4	4
Insufficient Flow or Under Infusion	3	3
Device Alarm System	2	2
Pumping Problem	2	2
Device Displays Incorrect Message	2	2
Expiration Date Error	2	3
Therapeutic or Diagnostic Output Failure	2	2
Priming Problem	2	2
Human-Device Interface Problem	2	2
Misassembled	2	2
Noise, Audible	1	1
Display or Visual Feedback Problem	1	1
Nonstandard Device	1	1
Appropriate Term/Code Not Available	1	1
Protective Measures Problem	1	1
Contamination of Device Ingredient or Reagent	1	1
Infusion or Flow Problem	1	1
Excess Flow or Over-Infusion	1	2
Improper Flow or Infusion	1	1
Obstruction of Flow	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Air/Gas in Device	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Positioning Problem	1	1
Material Puncture/Hole	1	1
Complete Blockage	1	1
Device Markings/Labelling Problem	1	1
Off-Label Use	1	1
Break	1	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	151	163
Low Blood Pressure/ Hypotension	69	97
Hemolysis	52	54
Hypersensitivity/Allergic reaction	48	72
Insufficient Information	43	51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	35	57
Itching Sensation	30	35
Rash	28	30
Tachycardia	21	24
Vomiting	18	29
Local Reaction	18	26
Nausea	17	19
Hypervolemia	16	16
Fever	16	16
Urticaria	14	14
Dyspnea	14	15
Air Embolism	13	13
Paresthesia	13	22
Anemia	12	12
Dizziness	11	13
Syncope/Fainting	10	11
High Blood Pressure/ Hypertension	9	9
Chest Pain	9	9
Hemorrhage/Bleeding	8	8
Thrombocytopenia	8	8
Sepsis	8	21
Convulsion/Seizure	7	7
Numbness	7	8
Chills	7	7
Electrolyte Imbalance	7	30
Pulmonary Embolism	6	6
Swelling/ Edema	6	7
Heart Failure/Congestive Heart Failure	6	6
Diarrhea	6	16
Loss of consciousness	5	5
Bacterial Infection	5	7
Bradycardia	5	5
Pain	5	5
Cardiac Arrest	5	5
Cramp(s) /Muscle Spasm(s)	5	5
Malaise	5	5
Liver Failure	5	5
Hematoma	5	5
Abdominal Pain	4	4
Erythema	4	6
Headache	4	4
Arrhythmia	4	4
Cough	4	4
Hypovolemia	3	3
Low Oxygen Saturation	3	3