TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	1776	1776
Protective Measures Problem	1232	1232
Excess Flow or Over-Infusion	357	357
Failure to Deliver	269	269
Air/Gas in Device	221	221
Use of Device Problem	102	102
Infusion or Flow Problem	98	98
Insufficient Flow or Under Infusion	89	89
Detachment of Device or Device Component	87	87
Inaccurate Delivery	56	56
Failure to Auto Stop	52	52
Leak/Splash	47	47
Human-Device Interface Problem	35	35
Inaccurate Flow Rate	33	33
Improper Flow or Infusion	17	17
Break	16	16
Mechanical Problem	12	12
Device Alarm System	10	10
Defective Device	10	10
Increased Pump Speed	9	9
Improper or Incorrect Procedure or Method	9	9
Failure to Power Up	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Fire	8	8
Obstruction of Flow	7	7
Material Puncture/Hole	6	6
Battery Problem	5	5
Material Separation	5	5
Appropriate Term/Code Not Available	5	5
Disconnection	5	5
Crack	4	4
No Audible Alarm	4	4
Device Displays Incorrect Message	4	4
Electrical /Electronic Property Problem	3	3
Free or Unrestricted Flow	3	3
Material Rupture	3	3
Device Fell	2	2
Therapeutic or Diagnostic Output Failure	2	2
Power Problem	2	2
Patient Device Interaction Problem	2	2
Pumping Stopped	2	2
Electrical Power Problem	2	2
Flushing Problem	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Insufficient Information	1	1
Defective Component	1	1
Material Integrity Problem	1	1
Short Fill	1	1
Complete Blockage	1	1
Pumping Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2256	2256
No Consequences Or Impact To Patient	1348	1348
No Known Impact Or Consequence To Patient	414	414
No Patient Involvement	124	124
Insufficient Information	102	102
No Information	74	74
Vomiting	34	34
Dyskinesia	15	15
Ambulation Difficulties	14	14
Nausea	14	14
Abdominal Distention	14	14
Discomfort	14	14
Hypoglycemia	9	9
Feeding Problem	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Overdose	6	6
Muscle Spasm(s)	6	6
Abdominal Pain	5	5
Weight Changes	5	5
Shaking/Tremors	5	5
Anxiety	5	5
No Code Available	5	5
Dyspnea	5	5
Cognitive Changes	5	5
Urinary Retention	4	4
Tachycardia	3	3
Pain	3	3
Flatus	3	3
Sleep Dysfunction	3	3
Device Overstimulation of Tissue	3	3
Malaise	3	3
Death	3	3
Fatigue	3	3
Lethargy	2	2
Distress	2	2
Visual Disturbances	2	2
Fever	2	2
Twitching	2	2
Abdominal Cramps	2	2
Dementia	2	2
Fall	2	2
Aspiration/Inhalation	2	2
Electric Shock	2	2
Full thickness (Third Degree) Burn	1	1
Respiratory Failure	1	1
Low Oxygen Saturation	1	1
Constipation	1	1
Inadequate Pain Relief	1	1
Headache	1	1
Dysphasia	1	1