TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	145	145
Crack	87	87
Mechanical Problem	45	45
Material Integrity Problem	29	29
Obstruction of Flow	19	19
Optical Problem	18	18
Material Deformation	17	17
Insufficient Information	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
Device Alarm System	14	14
Noise, Audible	11	11
Leak/Splash	10	10
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
Detachment of Device or Device Component	3	31
Delivered as Unsterile Product	3	3
Infusion or Flow Problem	3	3
Material Discolored	3	3
Contamination /Decontamination Problem	3	3
Disconnection	3	3
Break	3	3
Therapeutic or Diagnostic Output Failure	3	3
Defective Device	3	3
Loose or Intermittent Connection	2	2
Burst Container or Vessel	2	2
Fracture	2	2
Material Separation	2	2
Use of Device Problem	2	2
Contamination	2	2
Manufacturing, Packaging or Shipping Problem	1	1
Decrease in Suction	1	1
Blocked Connection	1	1
Defective Component	1	1
Unsealed Device Packaging	1	1
Sharp Edges	1	1
Misconnection	1	1
Unclear Information	1	1
Calibration Problem	1	1
Device Markings/Labelling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	260	288
Hemorrhage/Bleeding	83	83
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
Air Embolism	1	1
Unspecified Infection	1	1
Inflammation	1	1
Anemia	1	1
Local Reaction	1	1
Cognitive Changes	1	1
Blister	1	1
Cardiac Arrest	1	1
Renal Failure	1	1
Sudden Cardiac Death	1	1
Cough	1	1
Skin Tears	1	1
Ruptured Aneurysm	1	1
Unspecified Heart Problem	1	1
Hemothorax	1	1
Low Oxygen Saturation	1	1
Pulmonary Embolism	1	1
Aspiration Pneumonitis	1	1