TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	166	166
Mechanical Problem	71	71
Crack	39	39
Material Deformation	35	35
Optical Problem	29	29
Material Integrity Problem	29	29
Obstruction of Flow	25	25
Device Alarm System	20	20
Electrical /Electronic Property Problem	19	19
Noise, Audible	18	18
Nonstandard Device	15	15
Device Misassembled During Manufacturing /Shipping	15	15
Material Puncture/Hole	12	12
Insufficient Information	12	12
Air/Gas in Device	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Break	6	6
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
Gas/Air Leak	3	4
Use of Device Problem	3	3
Disconnection	3	3
Contamination	2	2
Therapeutic or Diagnostic Output Failure	2	2
Material Twisted/Bent	2	2
Infusion or Flow Problem	2	2
Delivered as Unsterile Product	2	2
Material Separation	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
Manufacturing, Packaging or Shipping Problem	1	1
Decrease in Suction	1	1
Blocked Connection	1	1
Defective Device	1	1
Sharp Edges	1	1
Unsealed Device Packaging	1	1
Unclear Information	1	1
Incorrect Measurement	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	316	327
Hemorrhage/Bleeding	122	122
Insufficient Information	15	17
Unspecified Blood or Lymphatic problem	12	12
Hemolysis	5	5
Hypovolemia	5	5
Low Cardiac Output	3	3
Low Blood Pressure/ Hypotension	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
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
Anemia	1	1
Local Reaction	1	1
Cognitive Changes	1	1
Blister	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