TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	129	129
Crack	82	82
Mechanical Problem	41	41
Material Integrity Problem	29	29
Insufficient Information	18	18
Obstruction of Flow	17	17
Electrical /Electronic Property Problem	16	16
Nonstandard Device	15	15
Adverse Event Without Identified Device or Use Problem	15	15
Device Misassembled During Manufacturing /Shipping	15	15
Optical Problem	13	13
Material Deformation	13	13
Device Alarm System	12	12
Leak/Splash	10	10
Noise, Audible	9	9
Material Puncture/Hole	7	7
Gas/Air Leak	6	6
Suction Problem	5	5
Appropriate Term/Code Not Available	5	5
Air/Gas in Device	5	5
Improper or Incorrect Procedure or Method	4	4
Smoking	4	4
Material Twisted/Bent	4	4
Connection Problem	3	3
No Apparent Adverse Event	3	3
Delivered as Unsterile Product	3	3
Infusion or Flow Problem	3	3
Material Discolored	3	3
Contamination /Decontamination Problem	3	3
Disconnection	3	3
Therapeutic or Diagnostic Output Failure	3	3
Defective Device	3	3
Contamination	2	2
Use of Device Problem	2	2
Loose or Intermittent Connection	2	2
Break	2	2
Burst Container or Vessel	2	2
Fracture	2	2
Detachment of Device or Device Component	2	16
Temperature Problem	1	1
Increase in Suction	1	1
Device Displays Incorrect Message	1	1
Chemical Problem	1	1
Pressure Problem	1	1
Overheating of Device	1	1
Material Split, Cut or Torn	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Off-Label Use	1	1
Reflux within Device	1	1
Free or Unrestricted Flow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	234	248
Hemorrhage/Bleeding	76	76
No Known Impact Or Consequence To Patient	41	41
Insufficient Information	15	15
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
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Pneumothorax	3	3
Hemolysis	3	3
Low Blood Pressure/ Hypotension	3	3
Respiratory Distress	2	2
Low Cardiac Output	2	2
Thrombosis/Thrombus	2	2
Pleural Effusion	2	2
Bradycardia	2	2
Unspecified Infection	1	1
Air Embolism	1	1
Inflammation	1	1
Local Reaction	1	1
Blister	1	1
Cognitive Changes	1	1
Anemia	1	1
Cardiac Arrest	1	1
Sudden Cardiac Death	1	1
Cough	1	1
Renal Failure	1	1
Skin Tears	1	1
Ruptured Aneurysm	1	1
Unspecified Heart Problem	1	1
Bacterial Infection	1	1
Hemothorax	1	1
Low Oxygen Saturation	1	1
Pulmonary Embolism	1	1
Aspiration Pneumonitis	1	1