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
Mechanical Problem	12	12
Component Missing	11	12
Noise, Audible	11	11
Delivered as Unsterile Product	10	10
Increase in Pressure	8	8
Break	7	7
Material Split, Cut or Torn	7	7
Component Misassembled	7	7
Packaging Problem	6	6
Fracture	5	6
Detachment of Device or Device Component	5	5
No Flow	5	5
Gas/Air Leak	4	4
No Apparent Adverse Event	4	4
Infusion or Flow Problem	4	4
Material Twisted/Bent	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
Decrease in Pressure	2	2
Coagulation in Device or Device Ingredient	2	2
Insufficient Device Problem Information	2	2
Chemical Problem	2	2
Insufficient Flow or Under Infusion	2	2
Improper Flow or Infusion	2	2
Output Problem	2	2
Defective Component	1	1
Pumping Problem	1	1
Deformation Due to Compressive Stress	1	1
Device Alarm System	1	1
Unexpected Therapeutic Results	1	1
Pressure Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Compatibility Problem	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	678	684
Hemorrhage/Blood Loss/Bleeding	116	119
No Consequences Or Impact To Patient	29	29
Insufficient Information	12	12
Air Embolism	7	7
No Patient Involvement	6	6
Hypovolemia	6	6
No Known Impact Or Consequence To Patient	6	6
Low Oxygen Saturation	5	5
Blood Loss	4	4
Death	3	3
Hypoxia	2	2
Ischemia	2	2
Low Blood Pressure/ Hypotension	2	2
Bradycardia	2	2
Paralysis	1	1
Adult Respiratory Distress Syndrome	1	1
Hemolysis	1	1
Thrombosis/Thrombus	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
Internal Organ Perforation	1	1
Ischemia Stroke	1	1
Embolism/Embolus	1	1
Pericardial Effusion	1	1
Pulmonary Embolism	1	1
Cardiac Perforation	1	1
Thrombosis	1	1

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