TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	2546	5253
Filling Problem	2486	2958
No Flow	1024	1277
Material Rupture	1006	1308
Excess Flow or Over-Infusion	697	697
Infusion or Flow Problem	276	276
Device Contamination with Chemical or Other Material	205	354
Break	173	195
Leak/Splash	100	100
Disconnection	100	100
Adverse Event Without Identified Device or Use Problem	94	94
Failure to Infuse	66	66
Component Missing	66	69
Improper Flow or Infusion	59	59
Crack	56	60
Contamination /Decontamination Problem	44	44
Detachment of Device or Device Component	43	43
Loose or Intermittent Connection	29	30
Inaccurate Flow Rate	26	26
Insufficient Flow or Under Infusion	25	25
Material Split, Cut or Torn	23	24
Backflow	18	18
Material Twisted/Bent	17	17
Material Deformation	16	16
Failure to Deliver	15	15
Failure to Prime	12	12
Physical Resistance/Sticking	11	11
Pumping Problem	9	9
Improper or Incorrect Procedure or Method	8	8
Use of Device Problem	7	7
Device Contaminated During Manufacture or Shipping	7	7
Obstruction of Flow	7	7
Material Integrity Problem	6	6
Defective Component	6	6
Priming Problem	5	5
Material Separation	5	5
Material Puncture/Hole	5	8
Air/Gas in Device	5	5
Defective Device	5	5
Fracture	5	5
Inaccurate Delivery	4	4
Precipitate in Device or Device Ingredient	4	4
Deflation Problem	4	4
Material Fragmentation	4	4
Scratched Material	3	3
Patient-Device Incompatibility	3	3
Therapeutic or Diagnostic Output Failure	3	3
Degraded	3	3
Product Quality Problem	2	2
Cross Reactivity	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4734	4734
No Patient Involvement	1894	3974
No Consequences Or Impact To Patient	1428	2260
No Known Impact Or Consequence To Patient	413	1440
Insufficient Information	149	149
Pain	56	56
Nausea	49	49
Numbness	34	34
No Code Available	33	33
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
Foreign Body In Patient	27	27
Chemical Exposure	22	22
Tinnitus	21	21
Vomiting	19	19
Malaise	19	19
Discomfort	18	18
Fatigue	15	15
Dizziness	15	15
Abdominal Pain	14	14
No Information	13	13
Tachycardia	12	12
Dyspnea	11	11
Fever	11	11
Hot Flashes/Flushes	11	11
Diarrhea	11	11
Taste Disorder	11	11
Inadequate Pain Relief	10	10
Overdose	10	10
High Blood Pressure/ Hypertension	9	9
Chest Pain	9	9
Swelling/ Edema	7	7
Rash	7	7
Lethargy	7	7
Diaphoresis	6	6
Muscle Weakness	6	6
Death	5	5
Inflammation	5	5
Blurred Vision	5	5
Low Blood Pressure/ Hypotension	5	5
Bacterial Infection	5	5
Swelling	5	5
Burning Sensation	4	4
Thromboembolism	4	4
Underdose	4	4
Chills	4	4
Anxiety	4	4
Nerve Damage	4	4
Arrhythmia	3	3
Peeling	3	3
Pulmonary Embolism	3	3