TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	187	187
Mechanical Problem	84	84
Material Deformation	41	41
Crack	39	39
Optical Problem	33	33
Material Integrity Problem	31	31
Obstruction of Flow	27	27
Device Alarm System	23	23
Noise, Audible	23	23
Electrical /Electronic Property Problem	19	19
Device Misassembled During Manufacturing /Shipping	15	15
Nonstandard Device	15	15
Material Puncture/Hole	13	13
Insufficient Device Problem Information	12	12
Air/Gas in Device	10	10
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	3	3
Appropriate Device Problem Term/Code Not Available	3	3
Detachment of Device or Device Component	3	11
Use of Device Problem	3	3
Leak/Splash	2	2
Fracture	2	2
Disconnection	2	2
Connection Problem	2	2
Contamination	2	2
Burst Container or Vessel	2	2
Infusion or Flow Problem	2	2
Material Twisted/Bent	2	2
Unclear Information	1	1
Increase in Suction	1	1
Temperature Problem	1	1
Device Contamination with Body Fluid	1	1
Off-Label Use	1	1
Application Program Freezes or Fails to Launch	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Misassembled During Installation	1	1
Unsealed Device Packaging	1	1
Incorrect Measurement	1	1
Overheating of Device	1	1
Power Problem	1	1
Decrease in Suction	1	1
Chemical Problem	1	1
Blocked Connection	1	1
Gas/Air Leak	1	1
Sharp Edges	1	1
Suction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	357	368
Hemorrhage/Blood Loss/Bleeding	141	141
Insufficient Information	16	18
Unspecified Blood or Lymphatic problem	12	12
Hypovolemia	5	5
Hemolysis	5	5
Perforation of Vessels	3	3
Low Cardiac Output	3	3
Low Blood Pressure/ Hypotension	3	3
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	3	3
Unspecified Tissue Injury	2	2
Pneumothorax	2	2
Thrombosis/Thrombus	2	2
Renal Failure	2	2
Bradycardia	2	2
Cognitive Changes	1	1
Ruptured Aneurysm	1	1
No Information	1	1
Pulmonary Embolism	1	1
Blister	1	1
Anemia	1	1
Dyspnea	1	1
Inflammation	1	1
Aspiration Pneumonitis	1	1
Post Operative Wound Infection	1	1
Local Reaction	1	1
No Consequences Or Impact To Patient	1	1
Cardiac Arrest	1	1
Myocardial Contusion	1	1
Low Oxygen Saturation	1	1
Cough	1	1
Unspecified Heart Problem	1	1
Kidney injury	1	1
Skin Tears	1	1