TPLC - Total Product Life Cycle

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Device	heat-exchanger, cardiopulmonary bypass
Regulation Description	Cardiopulmonary bypass heat exchanger.
Product Code	DTR
Regulation Number	870.4240
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	29	29
Device Displays Incorrect Message	9	9
Defective Device	5	5
Infusion or Flow Problem	5	5
Leak/Splash	4	4
Air/Gas in Device	4	4
Material Puncture/Hole	3	3
Defective Component	3	3
Improper Flow or Infusion	3	3
Excess Flow or Over-Infusion	3	3
No Apparent Adverse Event	3	3
Appropriate Term/Code Not Available	3	3
Therapeutic or Diagnostic Output Failure	2	2
Use of Device Problem	2	2
Gas/Air Leak	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Material Separation	2	2
Inaccurate Delivery	2	2
Protective Measures Problem	2	2
Loss of Power	2	2
Device Contaminated During Manufacture or Shipping	1	1
Pressure Problem	1	1
Mechanical Problem	1	1
Output Problem	1	1
Material Integrity Problem	1	1
Contamination	1	1
Pumping Stopped	1	1
Microbial Contamination of Device	1	1
Visual Prompts will not Clear	1	1
No Pressure	1	1
Backflow	1	1
Obstruction of Flow	1	1
Particulates	1	1
Detachment of Device or Device Component	1	1
Device Sensing Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Connection Problem	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	60	60
No Consequences Or Impact To Patient	25	25
Insufficient Information	7	7
Electrolyte Imbalance	4	4
Overdose	2	2
Cardiac Arrest	1	1
No Known Impact Or Consequence To Patient	1	1
Bacterial Infection	1	1
Hemorrhage/Bleeding	1	1