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	37	37
Adverse Event Without Identified Device or Use Problem	25	25
Insufficient Information	17	17
Incorrect Measurement	17	17
Incorrect, Inadequate or Imprecise Result or Readings	13	13
Break	12	12
Detachment of Device or Device Component	11	11
Pressure Problem	10	10
Use of Device Problem	9	9
Device Operates Differently Than Expected	9	9
Infusion or Flow Problem	7	7
Defective Device	7	7
Output Problem	7	7
Fluid/Blood Leak	6	6
Defective Component	5	5
Improper Flow or Infusion	5	5
Volume Accuracy Problem	5	5
Display or Visual Feedback Problem	5	5
Excess Flow or Over-Infusion	4	4
Nonstandard Device	4	4
Suction Problem	4	4
Application Program Problem	4	4
Mechanical Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Device Displays Incorrect Message	4	4
Material Separation	4	4
Material Rupture	4	4
Insufficient Flow or Under Infusion	3	3
Mechanics Altered	2	2
Pumping Stopped	2	2
Shipping Damage or Problem	2	2
Connection Problem	2	2
Air/Gas in Device	2	2
Therapeutic or Diagnostic Output Failure	2	2
Suction Failure	2	2
Crack	2	2
Burst Container or Vessel	2	2
Calibration Problem	2	2
Loose or Intermittent Connection	2	2
Inaccurate Dispensing	2	2
Packaging Problem	2	2
Device Inoperable	2	2
Increase in Pressure	2	2
Fracture	2	2
Protective Measures Problem	2	2
Low Readings	1	1
Lack of Effect	1	1
Failure to Cut	1	1
Material Split, Cut or Torn	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	55	55
No Consequences Or Impact To Patient	41	41
Insufficient Information	22	22
Hypervolemia	10	10
No Code Available	8	8
No Information	8	8
No Patient Involvement	8	8
Pulmonary Edema	6	6
Perforation	5	5
Air Embolism	4	4
Unspecified Heart Problem	4	4
Cardiac Arrest	3	3
Swelling	3	3
Uterine Perforation	2	2
Death	2	2
Hyponatremia	2	2
Pulmonary Embolism	2	2
Edema	2	2
Loss of consciousness	2	2
Unspecified Tissue Injury	2	2
Extravasation	2	2
Distress	1	1
Hypovolemia	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
Extubate	1	1
Underdose	1	1
Hyperventilation	1	1
Bronchospasm	1	1
Bradycardia	1	1
Unspecified Kidney or Urinary Problem	1	1
Cardiopulmonary Arrest	1	1
Laceration(s)	1	1
Dehydration	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
Electrolyte Imbalance	1	1
Atrial Fibrillation	1	1
Blood Loss	1	1
Peritoneal Laceration(s)	1	1
Ischemic Heart Disease	1	1
Embolism/Embolus	1	1