TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	178	178
Mechanical Problem	79	79
Material Deformation	41	41
Crack	39	39
Optical Problem	32	32
Material Integrity Problem	30	30
Obstruction of Flow	25	25
Noise, Audible	23	23
Device Alarm System	22	22
Electrical /Electronic Property Problem	19	19
Device Misassembled During Manufacturing /Shipping	15	15
Nonstandard Device	15	15
Material Puncture/Hole	13	13
Insufficient Information	12	12
Adverse Event Without Identified Device or Use Problem	10	10
Air/Gas in Device	10	10
Delivered as Unsterile Product	8	8
Break	7	7
Leak/Splash	4	6
Smoking	4	4
Connection Problem	3	3
Detachment of Device or Device Component	3	11
Material Separation	3	3
Use of Device Problem	3	3
Improper or Incorrect Procedure or Method	3	3
Disconnection	3	3
Gas/Air Leak	3	4
Appropriate Term/Code Not Available	3	3
No Apparent Adverse Event	3	4
Therapeutic or Diagnostic Output Failure	2	2
Infusion or Flow Problem	2	2
Material Twisted/Bent	2	2
Contamination	2	2
Burst Container or Vessel	2	2
Loose or Intermittent Connection	2	2
Fracture	2	2
Inadequate Instructions for Healthcare Professional	1	1
Incorrect Measurement	1	1
Overheating of Device	1	1
Unsealed Device Packaging	1	1
Off-Label Use	1	1
Coagulation in Device or Device Ingredient	1	1
Decrease in Suction	1	1
Suction Problem	1	1
Device Contamination with Body Fluid	1	1
Inadequacy of Device Shape and/or Size	1	1
Reflux within Device	1	1
Device Markings/Labelling Problem	1	1
Increase in Suction	1	1
Defective Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	339	350
Hemorrhage/Bleeding	134	134
Insufficient Information	16	18
Unspecified Blood or Lymphatic problem	12	12
Hemolysis	5	5
Hypovolemia	5	5
Perforation of Vessels	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Low Cardiac Output	3	3
Low Blood Pressure/ Hypotension	3	3
Pneumothorax	2	2
Thrombosis/Thrombus	2	2
Bradycardia	2	2
Renal Failure	2	2
Unspecified Tissue Injury	2	2
No Information	1	1
Inflammation	1	1
Anemia	1	1
Local Reaction	1	1
Cognitive Changes	1	1
Blister	1	1
Cardiac Arrest	1	1
Post Operative Wound Infection	1	1
Myocardial Contusion	1	1
Dyspnea	1	1
Cough	1	1
Skin Tears	1	1
Ruptured Aneurysm	1	1
Unspecified Heart Problem	1	1
No Consequences Or Impact To Patient	1	1
Low Oxygen Saturation	1	1
Pulmonary Embolism	1	1
Aspiration Pneumonitis	1	1