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	425	469
Insufficient Information	318	318
No Apparent Adverse Event	71	71
Use of Device Problem	23	23
Patient-Device Incompatibility	21	21
Improper or Incorrect Procedure or Method	12	12
Device Displays Incorrect Message	7	7
Insufficient Flow or Under Infusion	7	7
Fluid/Blood Leak	6	6
Appropriate Term/Code Not Available	5	5
Device Handling Problem	5	5
Output Problem	5	5
Infusion or Flow Problem	5	5
Device Alarm System	5	5
Therapeutic or Diagnostic Output Failure	5	5
Misassembled	4	4
Improper Flow or Infusion	4	4
Gas/Air Leak	4	4
Obstruction of Flow	4	4
Mechanical Problem	4	4
Inadequate User Interface	4	4
Device Slipped	4	4
Defective Device	3	3
Defective Component	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Microbial Contamination of Device	2	2
Contamination /Decontamination Problem	2	2
Air/Gas in Device	2	2
Backflow	2	2
Expiration Date Error	2	2
Display or Visual Feedback Problem	2	2
Inaccurate Flow Rate	2	2
Excess Flow or Over-Infusion	2	2
Pumping Problem	2	2
Off-Label Use	2	2
Component Misassembled	2	2
Human-Device Interface Problem	2	2
Coagulation in Device or Device Ingredient	2	2
Improper Chemical Reaction	1	1
Difficult to Open or Close	1	1
No Flow	1	1
Self-Activation or Keying	1	1
Priming Problem	1	1
Noise, Audible	1	1
Nonstandard Device	1	1
Protective Measures Problem	1	1
Inaccurate Delivery	1	1
Contamination of Device Ingredient or Reagent	1	1
High Test Results	1	1
Structural Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	147	147
Low Blood Pressure/ Hypotension	66	88
Hemolysis	49	49
Hypersensitivity/Allergic reaction	43	65
Insufficient Information	43	43
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	35	57
Reaction	35	35
Death	28	28
Rash	26	26
Itching Sensation	25	25
No Known Impact Or Consequence To Patient	23	23
Tachycardia	18	18
Hypervolemia	16	16
Nausea	16	16
Vomiting	15	24
Local Reaction	15	15
Anemia	14	14
Air Embolism	13	13
Dyspnea	13	13
Fever	13	13
Paresthesia	13	22
Urticaria	12	12
Syncope/Fainting	11	11
Sepsis	9	22
Dizziness	9	9
Chest Pain	9	9
Electrolyte Imbalance	9	31
Hemorrhage/Bleeding	8	8
Thrombocytopenia	8	8
High Blood Pressure/ Hypertension	7	7
Unspecified Infection	7	29
No Consequences Or Impact To Patient	7	7
Bacterial Infection	7	7
Hematoma	7	7
Cardiac Arrest	7	7
Pulmonary Embolism	6	6
Numbness	6	6
Low Oxygen Saturation	5	5
Malaise	5	5
Liver Failure	5	5
Diarrhea	5	14
Pain	5	5
Swelling/ Edema	5	5
Heart Failure/Congestive Heart Failure	5	5
Cramp(s) /Muscle Spasm(s)	4	4
Hypovolemia	4	4
Chills	4	4
Erythema	4	4
Arrhythmia	4	4
Convulsion/Seizure	4	4