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	352	390
Adverse Event Without Identified Device or Use Problem	336	415
No Apparent Adverse Event	69	71
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	3	3
Insufficient Flow or Under Infusion	3	3
Pumping Problem	2	2
Device Displays Incorrect Message	2	2
Expiration Date Error	2	3
Therapeutic or Diagnostic Output Failure	2	2
Human-Device Interface Problem	2	2
Misassembled	2	2
Noise, Audible	1	1
Display or Visual Feedback Problem	1	1
Priming 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
Device Alarm System	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	140	152
Low Blood Pressure/ Hypotension	64	92
Hypersensitivity/Allergic reaction	48	72
Hemolysis	44	46
Insufficient Information	40	48
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	35	57
Rash	28	30
Itching Sensation	28	33
Tachycardia	17	20
Local Reaction	17	25
Hypervolemia	16	16
Nausea	16	18
Vomiting	16	27
Dyspnea	14	15
Air Embolism	13	13
Paresthesia	13	22
Fever	13	13
Urticaria	13	13
Anemia	12	12
Dizziness	11	13
Syncope/Fainting	10	11
Chest Pain	9	9
High Blood Pressure/ Hypertension	8	8
Thrombocytopenia	8	8
Sepsis	8	21
Electrolyte Imbalance	7	30
Convulsion/Seizure	7	7
Diarrhea	6	16
Numbness	6	7
Heart Failure/Congestive Heart Failure	6	6
Hemorrhage/Bleeding	6	6
Pulmonary Embolism	6	6
Malaise	5	5
Hematoma	5	5
Pain	5	5
Bradycardia	5	5
Swelling/ Edema	5	6
Bacterial Infection	5	7
Chills	5	5
Liver Failure	5	5
Loss of consciousness	5	5
Erythema	4	6
Headache	4	4
Abdominal Pain	4	4
Cardiac Arrest	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Arrhythmia	4	4
Hypovolemia	3	3
Low Oxygen Saturation	3	3
Thrombosis/Thrombus	3	3