TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	174	174
Mechanical Problem	77	77
Material Deformation	40	40
Crack	39	39
Optical Problem	32	32
Material Integrity Problem	29	29
Obstruction of Flow	25	25
Noise, Audible	23	23
Device Alarm System	22	22
Electrical /Electronic Property Problem	19	19
Nonstandard Device	15	15
Device Misassembled During Manufacturing /Shipping	15	15
Material Puncture/Hole	13	13
Insufficient Information	12	12
Adverse Event Without Identified Device or Use Problem	10	10
Air/Gas in Device	10	10
Delivered as Unsterile Product	8	8
Break	7	7
Leak/Splash	4	6
Smoking	4	4
Improper or Incorrect Procedure or Method	3	3
Connection Problem	3	3
Appropriate Term/Code Not Available	3	3
No Apparent Adverse Event	3	4
Detachment of Device or Device Component	3	11
Material Separation	3	3
Gas/Air Leak	3	4
Use of Device Problem	3	3
Disconnection	3	3
Contamination	2	2
Material Twisted/Bent	2	2
Infusion or Flow Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Fracture	2	2
Burst Container or Vessel	2	2
Loose or Intermittent Connection	2	2
Misassembled During Installation	1	1
Contamination /Decontamination Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Decrease in Suction	1	1
Blocked Connection	1	1
Sharp Edges	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Defective Device	1	1
Unsealed Device Packaging	1	1
Incorrect Measurement	1	1
Unclear Information	1	1
Inadequacy of Device Shape and/or Size	1	1
Device Markings/Labelling Problem	1	1
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	334	345
Hemorrhage/Bleeding	131	131
Insufficient Information	16	18
Unspecified Blood or Lymphatic problem	12	12
Hemolysis	5	5
Hypovolemia	5	5
Perforation of Vessels	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Low Cardiac Output	3	3
Low Blood Pressure/ Hypotension	3	3
Pneumothorax	2	2
Thrombosis/Thrombus	2	2
Bradycardia	2	2
Renal Failure	2	2
Unspecified Tissue Injury	2	2
No Information	1	1
Inflammation	1	1
Local Reaction	1	1
Blister	1	1
Cognitive Changes	1	1
Anemia	1	1
Cardiac Arrest	1	1
Post Operative Wound Infection	1	1
Myocardial Contusion	1	1
Dyspnea	1	1
Cough	1	1
Skin Tears	1	1
Ruptured Aneurysm	1	1
Unspecified Heart Problem	1	1
No Consequences Or Impact To Patient	1	1
Low Oxygen Saturation	1	1
Pulmonary Embolism	1	1
Aspiration Pneumonitis	1	1