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
Noise, Audible	11	11
Component Missing	11	12
Delivered as Unsterile Product	10	10
Increase in Pressure	8	8
Material Split, Cut or Torn	7	7
Component Misassembled	7	7
Break	7	7
Packaging Problem	6	6
No Flow	5	5
Fracture	5	6
Detachment of Device or Device Component	5	5
No Apparent Adverse Event	4	4
Material Twisted/Bent	4	4
Infusion or Flow Problem	4	4
Gas/Air Leak	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Difficult to Remove	3	3
Decoupling	3	3
Contamination	3	3
Insufficient Flow or Under Infusion	2	2
Chemical Problem	2	2
Improper Flow or Infusion	2	2
Decrease in Pressure	2	2
Output Problem	2	2
Insufficient Device Problem Information	2	2
Coagulation in Device or Device Ingredient	2	2
Defective Component	1	1
Suction Problem	1	1
Deformation Due to Compressive Stress	1	1
Contamination /Decontamination Problem	1	1
Connection Problem	1	1
Unexpected Therapeutic Results	1	1
Difficult to Open or Remove Packaging Material	1	1
Filtration Problem	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	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
Cardiac Arrest	1	1
Ischemia Stroke	1	1
Hemolysis	1	1
Pulmonary Embolism	1	1
Paralysis	1	1
Pericardial Effusion	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Internal Organ Perforation	1	1
Adult Respiratory Distress Syndrome	1	1
Thrombosis	1	1
Heart Failure/Congestive Heart Failure	1	1
Embolism/Embolus	1	1
Cardiac Perforation	1	1
Thrombosis/Thrombus	1	1

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