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	411	418
Obstruction of Flow	67	67
Material Separation	66	68
Air/Gas in Device	55	57
Material Puncture/Hole	54	56
Crack	41	43
Material Deformation	38	38
Disconnection	35	35
Misassembled During Installation	31	31
Tear, Rip or Hole in Device Packaging	13	13
Mechanical Problem	12	12
Component Missing	11	12
Delivered as Unsterile Product	10	10
Misassembled	9	10
Increase in Pressure	8	8
Noise, Audible	7	7
Material Split, Cut or Torn	7	7
Component Misassembled	7	7
Leak/Splash	6	6
Break	6	6
Packaging Problem	6	6
Fracture	5	6
Detachment of Device or Device Component	5	5
No Apparent Adverse Event	4	4
Gas/Air Leak	4	4
Infusion or Flow Problem	4	4
Material Twisted/Bent	4	4
Device Misassembled During Manufacturing /Shipping	3	3
No Flow	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Decoupling	3	3
Difficult to Remove	3	3
Contamination	3	3
Decrease in Pressure	2	2
Chemical Problem	2	2
Insufficient Device Problem Information	2	2
Output Problem	2	2
Defective Component	1	1
Pumping Problem	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Device Alarm System	1	1
Unexpected Therapeutic Results	1	1
Difficult to Open or Remove Packaging Material	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Free or Unrestricted Flow	1	1
Compatibility Problem	1	1
Filtration Problem	1	1
Deformation Due to Compressive Stress	1	1
Loose or Intermittent Connection	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	673	679
Hemorrhage/Blood Loss/Bleeding	115	118
Insufficient Information	12	12
Air Embolism	7	7
No Consequences Or Impact To Patient	6	6
Hypovolemia	5	5
Hypoxia	2	2
Low Blood Pressure/ Hypotension	2	2
Low Oxygen Saturation	2	2
Internal Organ Perforation	1	1
Paralysis	1	1
Adult Respiratory Distress Syndrome	1	1
Hemolysis	1	1
Embolism/Embolus	1	1
Cardiac Arrest	1	1
Heart Failure/Congestive Heart Failure	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Bradycardia	1	1
Ischemia Stroke	1	1
Pulmonary Embolism	1	1
Pericardial Effusion	1	1
Cardiac Perforation	1	1