TPLC - Total Product Life Cycle

show TPLC since

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
Misassembled	14	15
Leak/Splash	14	14
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
No Apparent Adverse Event	4	4
Gas/Air Leak	4	4
Material Twisted/Bent	4	4
Infusion or Flow Problem	4	4
Difficult to Remove	3	3
Contamination	3	3
Decoupling	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Decrease in Pressure	2	2
Insufficient Device Problem Information	2	2
Output Problem	2	2
Improper Flow or Infusion	2	2
Chemical Problem	2	2
Insufficient Flow or Under Infusion	2	2
Coagulation in Device or Device Ingredient	2	2
Compatibility Problem	1	1
Free or Unrestricted Flow	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Filtration Problem	1	1
Difficult to Open or Remove Packaging Material	1	1
Pressure Problem	1	1
Pumping Problem	1	1
Connection Problem	1	1
Contamination /Decontamination Problem	1	1
Appropriate Device Problem Term/Code Not Available	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