TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	211	211
Crack	86	86
Mechanical Problem	84	84
Material Deformation	41	41
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
Insufficient Device Problem Information	17	17
Device Misassembled During Manufacturing /Shipping	15	15
Nonstandard Device	15	15
Adverse Event Without Identified Device or Use Problem	14	14
Material Puncture/Hole	13	13
Air/Gas in Device	10	10
Delivered as Unsterile Product	9	9
Break	7	7
Appropriate Device Problem Term/Code Not Available	5	5
No Apparent Adverse Event	5	6
Smoking	4	4
Material Separation	3	3
Infusion or Flow Problem	3	3
Detachment of Device or Device Component	3	11
Use of Device Problem	3	3
Leak/Splash	3	3
Contamination	2	2
Disconnection	2	2
Connection Problem	2	2
Material Twisted/Bent	2	2
Fracture	2	2
Burst Container or Vessel	2	2
Unclear Information	1	1
Increase in Suction	1	1
Temperature Problem	1	1
Device Contamination with Body Fluid	1	1
No Pressure	1	1
Application Program Freezes or Fails to Launch	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Gas/Air Leak	1	1
Off-Label Use	1	1
Incorrect Measurement	1	1
Overheating of Device	1	1
Power Problem	1	1
Unsealed Device Packaging	1	1
Chemical Problem	1	1
Decrease in Suction	1	1
Misassembled During Installation	1	1
Blocked Connection	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	375	386
Hemorrhage/Blood Loss/Bleeding	141	141
No Known Impact Or Consequence To Patient	41	41
Insufficient Information	18	20
No Consequences Or Impact To Patient	14	14
Unspecified Blood or Lymphatic problem	12	12
No Patient Involvement	11	11
No Information	6	6
Blood Loss	6	6
Death	5	5
Hypovolemia	5	5
Hemolysis	5	5
Low Blood Pressure/ Hypotension	4	4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	4	4
Perforation of Vessels	3	3
Low Cardiac Output	3	3
Pneumothorax	3	3
Thrombosis/Thrombus	2	2
Renal Failure	2	2
Pleural Effusion	2	2
Unspecified Tissue Injury	2	2
Respiratory Distress	2	2
Bradycardia	2	2
Air Embolism	1	1
Anemia	1	1
Local Reaction	1	1
Pulmonary Embolism	1	1
Cardiac Arrest	1	1
Ruptured Aneurysm	1	1
Low Oxygen Saturation	1	1
Inflammation	1	1
Aspiration Pneumonitis	1	1
Sudden Cardiac Death	1	1
Dyspnea	1	1
Post Operative Wound Infection	1	1
Unspecified Infection	1	1
Cough	1	1
Unspecified Heart Problem	1	1
Myocardial Contusion	1	1
Cognitive Changes	1	1
Kidney injury	1	1
Skin Tears	1	1
Hemothorax	1	1
Blister	1	1