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	424	431
Obstruction of Flow	67	67
Material Separation	66	68
Air/Gas in Device	55	57
Material Puncture/Hole	54	56
Disconnection	47	47
Crack	46	48
Material Deformation	38	38
Misassembled During Installation	31	31
Leak/Splash	21	21
Misassembled	15	16
Tear, Rip or Hole in Device Packaging	13	13
Delivered as Unsterile Product	13	13
Mechanical Problem	12	12
Noise, Audible	12	12
Component Missing	12	13
Component Misassembled	11	11
Packaging Problem	9	9
Break	8	8
Increase in Pressure	8	8
No Flow	7	7
Material Split, Cut or Torn	7	7
Pressure Problem	7	7
Infusion or Flow Problem	7	7
Insufficient Flow or Under Infusion	6	6
Fracture	5	6
No Apparent Adverse Event	5	5
Detachment of Device or Device Component	5	5
Coagulation in Device or Device Ingredient	4	4
Gas/Air Leak	4	4
Improper Flow or Infusion	4	4
Material Twisted/Bent	4	4
Decoupling	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Insufficient Device Problem Information	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Patient Device Interaction Problem	3	3
Difficult to Remove	3	3
Contamination	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Pumping Problem	3	3
Particulates	2	2
Decrease in Pressure	2	2
Chemical Problem	2	2
Output Problem	2	2
Compatibility Problem	1	1
Inaccurate Flow Rate	1	1
Contamination /Decontamination Problem	1	1
Failure to Read Input Signal	1	1
Pumping Stopped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	683	689
Hemorrhage/Blood Loss/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
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
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1

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