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
Adverse Event Without Identified Device or Use Problem	403	447
Insufficient Information	275	275
No Apparent Adverse Event	53	53
Use of Device Problem	34	34
Patient-Device Incompatibility	27	27
Improper or Incorrect Procedure or Method	16	16
Fluid/Blood Leak	16	16
Gas/Air Leak	12	12
Device Displays Incorrect Message	10	10
Insufficient Flow or Under Infusion	8	8
Obstruction of Flow	8	8
Infusion or Flow Problem	7	7
Output Problem	6	6
Therapeutic or Diagnostic Output Failure	6	6
Appropriate Term/Code Not Available	6	6
Leak/Splash	6	6
Excess Flow or Over-Infusion	5	5
Misassembled	5	5
Device Alarm System	5	5
Break	5	5
Device Handling Problem	5	5
Improper Flow or Infusion	5	5
Inadequate User Interface	5	5
Defective Device	5	5
Material Discolored	4	4
Mechanical Problem	4	4
Defective Component	4	4
Device Slipped	4	4
Coagulation in Device or Device Ingredient	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Microbial Contamination of Device	2	2
Contamination /Decontamination Problem	2	2
Contamination of Device Ingredient or Reagent	2	2
Off-Label Use	2	2
Display or Visual Feedback Problem	2	2
Inaccurate Flow Rate	2	2
Backflow	2	2
Expiration Date Error	2	2
Device Misassembled During Manufacturing /Shipping	2	2
Human-Device Interface Problem	2	2
Pumping Problem	2	2
Component Misassembled	2	2
Air/Gas in Device	2	2
Priming Problem	1	1
Noise, Audible	1	1
Improper Chemical Reaction	1	1
Difficult to Open or Close	1	1
Free or Unrestricted Flow	1	1
Pressure Problem	1	1
Protective Measures Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	127	127
Low Blood Pressure/ Hypotension	58	80
No Known Impact Or Consequence To Patient	57	57
Reaction	44	44
Insufficient Information	42	42
Hemolysis	42	42
Death	34	34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	33	55
Hypersensitivity/Allergic reaction	32	54
Itching Sensation	20	20
Rash	19	19
Hypervolemia	16	16
Tachycardia	16	16
Local Reaction	15	15
Vomiting	14	23
Dyspnea	14	14
Air Embolism	13	13
Fever	13	13
Nausea	13	13
Chest Pain	12	12
Anemia	12	12
Paresthesia	11	20
Electrolyte Imbalance	9	31
Sepsis	9	22
Hemorrhage/Bleeding	9	9
No Consequences Or Impact To Patient	9	9
Syncope/Fainting	9	9
Urticaria	9	9
Thrombocytopenia	8	8
Blood Loss	8	8
Cardiac Arrest	8	8
Bacterial Infection	7	7
Dizziness	7	7
Hematoma	7	7
Unspecified Infection	7	29
High Blood Pressure/ Hypertension	7	7
Swelling/ Edema	5	5
Heart Failure/Congestive Heart Failure	5	5
Pain	5	5
Liver Failure	5	5
Pulmonary Embolism	5	5
No Patient Involvement	5	5
Numbness	5	5
Diarrhea	5	14
Hypovolemia	5	5
No Information	4	4
Cramp(s) /Muscle Spasm(s)	4	4
Erythema	4	4
Hypoxia	3	3
Cough	3	3