TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	36	36
Device Displays Incorrect Message	19	19
Leak/Splash	8	8
Device Sensing Problem	6	6
Defective Device	6	6
Air/Gas in Device	5	5
Gas/Air Leak	5	5
No Apparent Adverse Event	3	3
Appropriate Term/Code Not Available	3	3
Use of Device Problem	3	3
Material Puncture/Hole	3	3
Defective Component	3	3
Material Separation	2	2
Loss of Power	2	2
Excess Flow or Over-Infusion	2	2
Inaccurate Delivery	2	2
Infusion or Flow Problem	2	2
Protective Measures Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Improper Flow or Infusion	1	1
Data Problem	1	1
Noise, Audible	1	1
Device Contaminated During Manufacture or Shipping	1	1
Material Integrity Problem	1	1
Mechanics Altered	1	1
No Flow	1	1
Adverse Event Without Identified Device or Use Problem	1	1
No Pressure	1	1
Output Problem	1	1
Pressure Problem	1	1
Obstruction of Flow	1	1
Visual Prompts will not Clear	1	1
Device Damaged Prior to Use	1	1
Difficult to Open or Close	1	1
Device Contamination with Chemical or Other Material	1	1
Connection Problem	1	1
Detachment of Device or Device Component	1	1
Device Emits Odor	1	1
Particulates	1	1
Device Alarm System	1	1
Backflow	1	1
Contamination	1	1
Display or Visual Feedback Problem	1	1
Electrical /Electronic Property Problem	1	1
Pumping Stopped	1	1
Microbial Contamination of Device	1	1
Solder Joint Fracture	1	1
Failure to Deliver	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	55	55
No Clinical Signs, Symptoms or Conditions	51	51
Insufficient Information	7	7
No Patient Involvement	5	5
Electrolyte Imbalance	3	3
Overdose	2	2
Bacterial Infection	1	1
Cardiac Arrest	1	1
No Known Impact Or Consequence To Patient	1	1
Blood Loss	1	1