TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Fragmentation	132	132
Adverse Event Without Identified Device or Use Problem	19	19
Insufficient Information	16	16
Leak/Splash	10	10
Incorrect Measurement	10	10
Use of Device Problem	10	10
Break	7	7
Output Problem	7	7
Infusion or Flow Problem	7	7
Pressure Problem	6	6
Incorrect, Inadequate or Imprecise Result or Readings	6	6
Increase in Pressure	4	4
Material Separation	4	4
Material Rupture	4	4
Application Program Problem	4	4
Improper Flow or Infusion	4	4
Fluid/Blood Leak	3	3
Mechanical Problem	3	3
Volume Accuracy Problem	3	3
Detachment of Device or Device Component	3	3
Improper or Incorrect Procedure or Method	2	2
Suction Problem	2	2
Fracture	2	2
Insufficient Flow or Under Infusion	2	2
Shipping Damage or Problem	2	2
Air/Gas in Device	2	2
Pumping Stopped	2	2
Therapeutic or Diagnostic Output Failure	2	2
Defective Device	2	2
Burst Container or Vessel	2	2
Suction Failure	2	2
Inadequate User Interface	1	1
No Device Output	1	1
Material Split, Cut or Torn	1	1
Device Displays Incorrect Message	1	1
Separation Problem	1	1
Loose or Intermittent Connection	1	1
Display or Visual Feedback Problem	1	1
Self-Activation or Keying	1	1
Connection Problem	1	1
Protective Measures Problem	1	1
Power Problem	1	1
False Negative Result	1	1
Off-Label Use	1	1
No Apparent Adverse Event	1	1
Communication or Transmission Problem	1	1
Low Readings	1	1
Physical Resistance/Sticking	1	1
Failure to Prime	1	1
Incomplete or Inadequate Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	233	233
Insufficient Information	27	27
No Known Impact Or Consequence To Patient	11	11
Hypervolemia	10	10
No Consequences Or Impact To Patient	6	6
Air Embolism	4	4
Perforation	4	4
Pulmonary Edema	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
Peritoneal Laceration(s)	1	1
Ischemic Heart Disease	1	1
Embolism/Embolus	1	1
Atrial Fibrillation	1	1
Blood Loss	1	1
Cardiac Arrest	1	1
Fever	1	1
Foreign Body In Patient	1	1
Thrombosis/Thrombus	1	1
Exposure to Body Fluids	1	1
Septic Shock	1	1
Unspecified Kidney or Urinary Problem	1	1
Bronchospasm	1	1
Unspecified Vascular Problem	1	1
Airway Obstruction	1	1
Low Blood Pressure/ Hypotension	1	1
Internal Organ Perforation	1	1
Low Oxygen Saturation	1	1
Pulmonary Embolism	1	1
Distress	1	1