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

Premarket Reviews
Manufacturer	Decision
LIVANOVA USA, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K233702 SMARxT Tubing and Connectors

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	39	39
Misassembled During Installation	31	31
Leak/Splash	14	14
Misassembled	14	15
Tear, Rip or Hole in Device Packaging	13	13
Mechanical Problem	12	12
Noise, Audible	11	11
Component Misassembled	11	11
Delivered as Unsterile Product	11	11
Component Missing	11	12
Increase in Pressure	8	8
Packaging Problem	7	7
Material Split, Cut or Torn	7	7
Break	7	7
No Flow	5	5
Detachment of Device or Device Component	5	5
Fracture	5	6
Gas/Air Leak	4	4
Material Twisted/Bent	4	4
Infusion or Flow Problem	4	4
No Apparent Adverse Event	4	4
Contamination	3	3
Difficult to Remove	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Decoupling	3	3
Chemical Problem	2	2
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
Loss of or Failure to Bond	1	1
Deformation Due to Compressive Stress	1	1
Loose or Intermittent Connection	1	1
Connection Problem	1	1
Suction Problem	1	1
Unexpected Therapeutic Results	1	1
Compatibility Problem	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Free or Unrestricted Flow	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	684	690
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