TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Fragmentation	132	132
Insufficient Information	23	23
Adverse Event Without Identified Device or Use Problem	20	20
Use of Device Problem	11	11
Pressure Problem	10	10
Output Problem	10	10
Break	9	9
Leak/Splash	6	6
Infusion or Flow Problem	6	6
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Improper Flow or Infusion	5	5
Incorrect Measurement	4	4
Material Separation	4	4
Increase in Pressure	4	4
Material Rupture	3	3
Device Contaminated During Manufacture or Shipping	3	3
Application Program Problem	3	3
Suction Failure	3	3
Mechanics Altered	2	2
Insufficient Flow or Under Infusion	2	2
Shipping Damage or Problem	2	2
Air/Gas in Device	2	2
High Readings	2	2
Pumping Stopped	2	2
Detachment of Device or Device Component	2	2
Therapeutic or Diagnostic Output Failure	2	2
Fracture	2	2
Defective Device	2	2
Pumping Problem	2	2
Communication or Transmission Problem	2	2
Volume Accuracy Problem	2	2
Mechanical Problem	2	2
Burst Container or Vessel	2	2
Improper or Incorrect Procedure or Method	2	2
No Apparent Adverse Event	1	1
Power Problem	1	1
Protective Measures Problem	1	1
Nonstandard Device	1	1
Low Readings	1	1
Suction Problem	1	1
Priming Problem	1	1
Failure to Analyze Signal	1	1
Failure to Prime	1	1
Display or Visual Feedback Problem	1	1
Loose or Intermittent Connection	1	1
Fluid/Blood Leak	1	1
Packaging Problem	1	1
Inadequate User Interface	1	1
Optical Problem	1	1
Calibration Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	255	255
Insufficient Information	27	27
Hypervolemia	11	11
Air Embolism	4	4
Perforation	4	4
Pulmonary Edema	4	4
Unspecified Heart Problem	4	4
Uterine Perforation	2	2
Hyponatremia	2	2
Unspecified Tissue Injury	2	2
Incomplete Induced Abortion	1	1
Embolism/Embolus	1	1
Ischemic Heart Disease	1	1
Peritoneal Laceration(s)	1	1
Atrial Fibrillation	1	1
Cardiac Arrest	1	1
Thrombosis/Thrombus	1	1
Exposure to Body Fluids	1	1
Unspecified Kidney or Urinary Problem	1	1
Asystole	1	1
Bradycardia	1	1
Bronchospasm	1	1
Loss of consciousness	1	1
Unspecified Vascular Problem	1	1
Airway Obstruction	1	1
Low Blood Pressure/ Hypotension	1	1
Internal Organ Perforation	1	1
Distress	1	1