TPLC - Total Product Life Cycle

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Device	tubing, pump, cardiopulmonary bypass
Product Code	DWE
Regulation Number	870.4390
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	382	382
Obstruction of Flow	55	55
Material Separation	50	50
Material Puncture/Hole	48	48
Disconnection	44	44
Air/Gas in Device	43	43
Crack	38	38
Material Deformation	36	36
Leak/Splash	26	26
Misassembled During Installation	20	20
Noise, Audible	15	15
Misassembled	14	14
Mechanical Problem	13	13
Tear, Rip or Hole in Device Packaging	13	13
Break	10	10
Pressure Problem	9	9
Component Missing	9	9
Increase in Pressure	8	8
No Flow	7	7
Material Split, Cut or Torn	7	7
Adverse Event Without Identified Device or Use Problem	6	6
Infusion or Flow Problem	6	6
Insufficient Flow or Under Infusion	6	6
Detachment of Device or Device Component	5	5
Packaging Problem	5	5
Defective Component	5	5
Coagulation in Device or Device Ingredient	4	4
Component Misassembled	4	4
Contamination	4	4
Improper Flow or Infusion	4	4
Gas/Air Leak	4	4
Loose or Intermittent Connection	3	3
Fracture	3	3
Decoupling	3	3
Material Twisted/Bent	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Patient Device Interaction Problem	3	3
Difficult to Remove	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Pumping Problem	3	3
Output Problem	3	3
Particulates	2	2
Therapeutic or Diagnostic Output Failure	2	2
Defective Device	2	2
Delivered as Unsterile Product	2	2
Chemical Problem	2	2
Mechanical Jam	2	2
Improper or Incorrect Procedure or Method	2	2
Connection Problem	2	2
No Apparent Adverse Event	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	574	574
Hemorrhage/Bleeding	94	94
No Known Impact Or Consequence To Patient	48	48
No Consequences Or Impact To Patient	41	41
No Patient Involvement	14	14
Death	12	12
Low Oxygen Saturation	9	9
Insufficient Information	8	8
Hypovolemia	6	6
Hemolysis	5	5
Blood Loss	4	4
Ischemia	3	3
Air Embolism	2	2
Stroke/CVA	2	2
Exsanguination	2	2
Injury	2	2
Thrombosis/Thrombus	2	2
Bradycardia	2	2
Hypoxia	2	2
Unspecified Infection	1	1
Patient Problem/Medical Problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Embolism/Embolus	1	1
Pericardial Effusion	1	1
Respiratory Acidosis	1	1
Paralysis	1	1
Cardiac Perforation	1	1
Thrombosis	1	1
Hypothermia	1	1
Heart Failure/Congestive Heart Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Internal Organ Perforation	1	1
Ischemia Stroke	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	LivaNova USA Inc.	III	Feb-27-2020