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	22	22
Leak/Splash	12	12
Incorrect Measurement	11	11
Use of Device Problem	11	11
Output Problem	10	10
Break	9	9
Infusion or Flow Problem	7	7
Incorrect, Inadequate or Imprecise Result or Readings	7	7
Pressure Problem	6	6
Improper Flow or Infusion	5	5
Material Rupture	4	4
Material Separation	4	4
Increase in Pressure	4	4
Application Program Problem	4	4
Suction Failure	3	3
Defective Device	3	3
Volume Accuracy Problem	3	3
Detachment of Device or Device Component	3	3
Mechanical Problem	3	3
Fluid/Blood Leak	3	3
Insufficient Flow or Under Infusion	3	3
Device Contaminated During Manufacture or Shipping	3	3
Pumping Problem	2	2
Material Puncture/Hole	2	2
Suction Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Improper or Incorrect Procedure or Method	2	2
Fracture	2	2
Pumping Stopped	2	2
Communication or Transmission Problem	2	2
High Readings	2	2
Air/Gas in Device	2	2
Shipping Damage or Problem	2	2
Failure to Prime	2	2
Burst Container or Vessel	2	2
Self-Activation or Keying	1	1
Failure to Analyze Signal	1	1
Display or Visual Feedback Problem	1	1
Priming Problem	1	1
Loose or Intermittent Connection	1	1
Connection Problem	1	1
Nonstandard Device	1	1
Protective Measures Problem	1	1
Power Problem	1	1
No Apparent Adverse Event	1	1
Device Displays Incorrect Message	1	1
Low Readings	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	256	256
Insufficient Information	28	28
No Known Impact Or Consequence To Patient	11	11
Hypervolemia	11	11
No Consequences Or Impact To Patient	6	6
Pulmonary Edema	5	5
Air Embolism	4	4
Perforation	4	4
Unspecified Heart Problem	4	4
No Patient Involvement	3	3
Uterine Perforation	2	2
Hyponatremia	2	2
No Code Available	2	2
Unspecified Tissue Injury	2	2
Loss of consciousness	2	2
Incomplete Induced Abortion	1	1
Bowel Perforation	1	1
Embolism/Embolus	1	1
Ischemic Heart Disease	1	1
Peritoneal Laceration(s)	1	1
Blood Loss	1	1
Atrial Fibrillation	1	1
Cardiac Arrest	1	1
Foreign Body In Patient	1	1
Fever	1	1
Thrombosis/Thrombus	1	1
Septic Shock	1	1
Exposure to Body Fluids	1	1
Unspecified Kidney or Urinary Problem	1	1
Asystole	1	1
Bradycardia	1	1
Bronchospasm	1	1
Unspecified Vascular Problem	1	1
Low Oxygen Saturation	1	1
Airway Obstruction	1	1
Low Blood Pressure/ Hypotension	1	1
Internal Organ Perforation	1	1
Pulmonary Embolism	1	1
Distress	1	1