TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	430	437
Obstruction of Flow	67	67
Material Separation	66	68
Air/Gas in Device	57	59
Material Puncture/Hole	54	56
Disconnection	49	49
Crack	47	49
Material Deformation	39	39
Misassembled During Installation	31	31
Leak/Splash	26	26
Misassembled	16	17
Noise, Audible	15	15
Break	14	14
Tear, Rip or Hole in Device Packaging	13	13
Mechanical Problem	12	12
Component Missing	12	13
Delivered as Unsterile Product	10	10
Increase in Pressure	9	9
Pressure Problem	9	9
No Flow	8	8
Detachment of Device or Device Component	8	8
Material Split, Cut or Torn	7	7
Component Misassembled	7	7
Infusion or Flow Problem	7	7
Packaging Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Insufficient Flow or Under Infusion	6	6
Gas/Air Leak	6	6
Fracture	5	6
No Apparent Adverse Event	5	5
Defective Component	5	5
Coagulation in Device or Device Ingredient	4	4
Material Twisted/Bent	4	4
Improper Flow or Infusion	4	4
Loose or Intermittent Connection	3	3
Connection Problem	3	3
Output Problem	3	3
Decoupling	3	3
Pumping Problem	3	3
Insufficient Information	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Contamination	3	3
Patient Device Interaction Problem	3	3
Difficult to Remove	3	3
Chemical Problem	2	2
Particulates	2	2
Decrease in Pressure	2	2
Defective Device	2	2
Therapeutic or Diagnostic Output Failure	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	676	682
Hemorrhage/Bleeding	116	119
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
Insufficient Information	12	12
Low Oxygen Saturation	11	11
Air Embolism	7	7
Hypovolemia	6	6
Blood Loss	4	4
Hemolysis	3	3
Ischemia	3	3
Stroke/CVA	2	2
Exsanguination	2	2
Injury	2	2
Bradycardia	2	2
Hypoxia	2	2
Low Blood Pressure/ Hypotension	2	2
Unspecified Infection	1	1
Patient Problem/Medical Problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Adult Respiratory Distress Syndrome	1	1
Embolism/Embolus	1	1
Pericardial Effusion	1	1
Cardiac Arrest	1	1
Respiratory Acidosis	1	1
Paralysis	1	1
Cardiac Perforation	1	1
Thrombosis/Thrombus	1	1
Thrombosis	1	1
Hypothermia	1	1
Heart Failure/Congestive Heart Failure	1	1
Internal Organ Perforation	1	1
Ischemia Stroke	1	1
Pulmonary Embolism	1	1

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