TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	162	162
Crack	88	88
Mechanical Problem	49	49
Material Integrity Problem	29	29
Optical Problem	22	22
Obstruction of Flow	20	20
Material Deformation	20	20
Electrical /Electronic Property Problem	17	17
Adverse Event Without Identified Device or Use Problem	17	17
Insufficient Information	17	17
Noise, Audible	16	16
Device Alarm System	15	15
Device Misassembled During Manufacturing /Shipping	15	15
Nonstandard Device	15	15
Leak/Splash	10	10
Material Puncture/Hole	8	8
Gas/Air Leak	6	6
Air/Gas in Device	6	6
Break	5	5
Suction Problem	5	5
Appropriate Term/Code Not Available	5	5
Smoking	4	4
Improper or Incorrect Procedure or Method	4	4
Material Twisted/Bent	4	4
Infusion or Flow Problem	3	3
Detachment of Device or Device Component	3	11
Connection Problem	3	3
Contamination /Decontamination Problem	3	3
Defective Device	3	3
Delivered as Unsterile Product	3	3
No Apparent Adverse Event	3	3
Therapeutic or Diagnostic Output Failure	3	3
Disconnection	3	3
Material Discolored	3	3
Loose or Intermittent Connection	2	2
Use of Device Problem	2	2
Material Separation	2	2
Fracture	2	2
Contamination	2	2
Burst Container or Vessel	2	2
Temperature Problem	1	1
Pressure Problem	1	1
No Pressure	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Device Contamination with Body Fluid	1	1
Material Split, Cut or Torn	1	1
Physical Resistance/Sticking	1	1
Sharp Edges	1	1
Application Program Freezes, Becomes Nonfunctional	1	1
Misassembled During Installation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	282	290
Hemorrhage/Bleeding	98	98
No Known Impact Or Consequence To Patient	41	41
Insufficient Information	17	17
No Consequences Or Impact To Patient	14	14
Unspecified Blood or Lymphatic problem	12	12
No Patient Involvement	11	11
Blood Loss	6	6
No Information	6	6
Death	5	5
Hypovolemia	5	5
Hemolysis	3	3
Low Blood Pressure/ Hypotension	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Pneumothorax	3	3
Low Cardiac Output	3	3
Bradycardia	2	2
Thrombosis/Thrombus	2	2
Pleural Effusion	2	2
Renal Failure	2	2
Respiratory Distress	2	2
Pulmonary Embolism	1	1
Air Embolism	1	1
Anemia	1	1
Cardiac Arrest	1	1
Myocardial Contusion	1	1
Hemothorax	1	1
Unspecified Infection	1	1
Inflammation	1	1
Blister	1	1
Ruptured Aneurysm	1	1
Unspecified Heart Problem	1	1
Aspiration Pneumonitis	1	1
Cough	1	1
Local Reaction	1	1
Post Operative Wound Infection	1	1
Low Oxygen Saturation	1	1
Sudden Cardiac Death	1	1
Skin Tears	1	1
Cognitive Changes	1	1