TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	190	190
Mechanical Problem	85	85
Material Deformation	43	43
Crack	39	39
Optical Problem	35	35
Material Integrity Problem	31	31
Obstruction of Flow	27	27
Noise, Audible	23	23
Device Alarm System	23	23
Electrical /Electronic Property Problem	21	21
Nonstandard Device	15	15
Device Misassembled During Manufacturing /Shipping	15	15
Material Puncture/Hole	13	13
Insufficient Device Problem Information	12	12
Air/Gas in Device	11	11
Adverse Event Without Identified Device or Use Problem	9	9
Delivered as Unsterile Product	8	8
Break	7	7
No Apparent Adverse Event	5	6
Smoking	4	4
Material Separation	4	4
Use of Device Problem	3	3
Detachment of Device or Device Component	3	11
Appropriate Device Problem Term/Code Not Available	3	3
Contamination	2	2
Material Twisted/Bent	2	2
Infusion or Flow Problem	2	2
Burst Container or Vessel	2	2
Fracture	2	2
Suction Problem	2	2
Connection Problem	2	2
Leak/Splash	2	2
Disconnection	2	2
Misassembled During Installation	1	1
Application Program Freezes or Fails to Launch	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Gas/Air Leak	1	1
Decrease in Suction	1	1
Blocked Connection	1	1
Unsealed Device Packaging	1	1
Sharp Edges	1	1
Unclear Information	1	1
Device Contamination with Body Fluid	1	1
Off-Label Use	1	1
Incorrect Measurement	1	1
Free or Unrestricted Flow	1	1
Power Problem	1	1
Coagulation in Device or Device Ingredient	1	1
Chemical Problem	1	1
Overheating of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	361	372
Hemorrhage/Blood Loss/Bleeding	146	146
Insufficient Information	16	18
Unspecified Blood or Lymphatic problem	12	12
Hemolysis	5	5
Hypovolemia	5	5
Low Cardiac Output	3	3
Perforation of Vessels	3	3
Low Blood Pressure/ Hypotension	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	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
Kidney injury	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