TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	1314	1314
Protective Measures Problem	1198	1198
Excess Flow or Over-Infusion	317	317
Failure to Deliver	247	247
Air/Gas in Device	229	229
Use of Device Problem	103	103
Infusion or Flow Problem	98	98
Insufficient Flow or Under Infusion	85	85
Detachment of Device or Device Component	53	53
Failure to Auto Stop	44	44
Inaccurate Delivery	43	43
Human-Device Interface Problem	35	35
Inaccurate Flow Rate	33	33
Improper Flow or Infusion	15	15
Mechanical Problem	11	11
Leak/Splash	10	10
Break	10	10
Defective Device	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Failure to Power Up	8	8
Improper or Incorrect Procedure or Method	7	7
Device Alarm System	7	7
Fire	6	6
Obstruction of Flow	6	6
Disconnection	5	5
Appropriate Term/Code Not Available	5	5
Increased Pump Speed	5	5
Battery Problem	5	5
Insufficient Information	4	4
No Audible Alarm	4	4
Device Displays Incorrect Message	3	3
Power Problem	3	3
Free or Unrestricted Flow	3	3
Material Separation	3	3
Material Rupture	3	3
Patient Device Interaction Problem	2	2
Pumping Stopped	2	2
Therapeutic or Diagnostic Output Failure	2	2
Electrical /Electronic Property Problem	2	2
Device Fell	2	2
Crack	2	2
Pumping Problem	2	2
Noise, Audible	1	1
Temperature Problem	1	1
Failure to Run on Battery	1	1
Device Remains Activated	1	1
Sparking	1	1
Material Split, Cut or Torn	1	1
Priming Problem	1	1
Complete Loss of Power	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2362	2362
No Consequences Or Impact To Patient	949	949
No Known Impact Or Consequence To Patient	186	186
Insufficient Information	102	102
No Information	48	48
No Patient Involvement	46	46
Vomiting	34	34
Nausea	14	14
Ambulation Difficulties	14	14
Discomfort	14	14
Dyskinesia	13	13
Abdominal Distention	12	12
Hypoglycemia	8	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Feeding Problem	7	7
Muscle Spasm(s)	6	6
Weight Changes	5	5
Abdominal Pain	5	5
No Code Available	5	5
Cognitive Changes	5	5
Overdose	5	5
Anxiety	5	5
Shaking/Tremors	5	5
Dyspnea	5	5
Sleep Dysfunction	3	3
Death	3	3
Fatigue	3	3
Malaise	3	3
Aspiration/Inhalation	3	3
Device Overstimulation of Tissue	3	3
Pain	3	3
Flatus	3	3
Urinary Retention	3	3
Lethargy	2	2
Distress	2	2
Dementia	2	2
Tachycardia	2	2
Dehydration	2	2
Fall	2	2
Twitching	2	2
Visual Disturbances	2	2
Abdominal Cramps	2	2
Muscular Rigidity	1	1
Loss of Range of Motion	1	1
Swelling	1	1
Fever	1	1
Hyperglycemia	1	1
Unspecified Mental, Emotional or Behavioural Problem	1	1
Choking	1	1
Weakness	1	1