TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Fragmentation	132	132
Leak/Splash	36	36
Adverse Event Without Identified Device or Use Problem	18	18
Incorrect Measurement	16	16
Insufficient Information	15	15
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Detachment of Device or Device Component	11	11
Use of Device Problem	9	9
Break	8	8
Output Problem	7	7
Defective Device	7	7
Pressure Problem	6	6
Infusion or Flow Problem	6	6
Display or Visual Feedback Problem	5	5
Fluid/Blood Leak	4	4
Nonstandard Device	4	4
Suction Problem	4	4
Material Separation	4	4
Application Program Problem	4	4
Defective Component	4	4
Improper Flow or Infusion	4	4
Material Rupture	4	4
Mechanical Problem	3	3
Increase in Pressure	2	2
Device Displays Incorrect Message	2	2
Improper or Incorrect Procedure or Method	2	2
Fracture	2	2
Loose or Intermittent Connection	2	2
Insufficient Flow or Under Infusion	2	2
Air/Gas in Device	2	2
Pumping Stopped	2	2
Shipping Damage or Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Packaging Problem	2	2
Crack	2	2
Suction Failure	2	2
Volume Accuracy Problem	2	2
Burst Container or Vessel	2	2
Lack of Effect	1	1
Delivered as Unsterile Product	1	1
Failure to Cut	1	1
Optical Problem	1	1
Excess Flow or Over-Infusion	1	1
Misconnection	1	1
Mechanics Altered	1	1
Calibration Problem	1	1
Connection Problem	1	1
Self-Activation or Keying	1	1
No Device Output	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	206	206
No Known Impact Or Consequence To Patient	36	36
No Consequences Or Impact To Patient	35	35
Insufficient Information	22	22
Hypervolemia	10	10
No Patient Involvement	7	7
No Information	5	5
Air Embolism	4	4
Perforation	4	4
Unspecified Heart Problem	4	4
Pulmonary Edema	4	4
No Code Available	3	3
Uterine Perforation	2	2
Pulmonary Embolism	2	2
Hyponatremia	2	2
Loss of consciousness	2	2
Unspecified Tissue Injury	2	2
Distress	1	1
Internal Organ Perforation	1	1
Low Blood Pressure/ Hypotension	1	1
Airway Obstruction	1	1
Low Oxygen Saturation	1	1
Unspecified Vascular Problem	1	1
Bronchospasm	1	1
Bradycardia	1	1
Unspecified Kidney or Urinary Problem	1	1
Cardiopulmonary Arrest	1	1
Laceration(s)	1	1
Exposure to Body Fluids	1	1
Septic Shock	1	1
Thrombosis/Thrombus	1	1
Fever	1	1
Foreign Body In Patient	1	1
Pallor	1	1
Cardiac Arrest	1	1
Atrial Fibrillation	1	1
Blood Loss	1	1
Peritoneal Laceration(s)	1	1
Ischemic Heart Disease	1	1
Embolism/Embolus	1	1
Heart Failure	1	1
Bowel Perforation	1	1
Brain Injury	1	1
Death	1	1
Incomplete Induced Abortion	1	1
Cyanosis	1	1