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	416	423
Obstruction of Flow	67	67
Material Separation	66	68
Air/Gas in Device	55	57
Material Puncture/Hole	54	56
Disconnection	45	45
Crack	44	46
Material Deformation	38	38
Misassembled During Installation	31	31
Leak/Splash	14	14
Misassembled	14	15
Tear, Rip or Hole in Device Packaging	13	13
Delivered as Unsterile Product	13	13
Mechanical Problem	12	12
Noise, Audible	11	11
Component Misassembled	11	11
Component Missing	11	12
Packaging Problem	9	9
Material Split, Cut or Torn	7	7
Break	7	7
Increase in Pressure	6	6
No Flow	5	5
Fracture	5	6
Detachment of Device or Device Component	5	5
No Apparent Adverse Event	4	4
Infusion or Flow Problem	4	4
Material Twisted/Bent	4	4
Gas/Air Leak	4	4
Device Misassembled During Manufacturing /Shipping	3	3
Decoupling	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Difficult to Remove	3	3
Contamination	3	3
Improper Flow or Infusion	2	2
Insufficient Device Problem Information	2	2
Decrease in Pressure	2	2
Insufficient Flow or Under Infusion	2	2
Output Problem	2	2
Coagulation in Device or Device Ingredient	2	2
Chemical Problem	2	2
Filtration Problem	1	1
Pumping Problem	1	1
Inaccurate Flow Rate	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Device Alarm System	1	1
Difficult to Open or Remove Packaging Material	1	1
Separation Problem	1	1
Pressure Problem	1	1
Contamination /Decontamination Problem	1	1
Compatibility Problem	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 Consequences Or Impact To Patient	29	29
Insufficient Information	12	12
Air Embolism	7	7
No Known Impact Or Consequence To Patient	6	6
No Patient Involvement	6	6
Hypovolemia	6	6
Low Oxygen Saturation	5	5
Blood Loss	4	4
Death	3	3
Ischemia	2	2
Bradycardia	2	2
Hypoxia	2	2
Low Blood Pressure/ Hypotension	2	2
Adult Respiratory Distress Syndrome	1	1
Hemolysis	1	1
Embolism/Embolus	1	1
Pericardial Effusion	1	1
Cardiac Arrest	1	1
Paralysis	1	1
Cardiac Perforation	1	1
Thrombosis/Thrombus	1	1
Thrombosis	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