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	415	415
Material Separation	66	66
Obstruction of Flow	66	66
Air/Gas in Device	57	57
Material Puncture/Hole	53	53
Crack	45	45
Disconnection	44	44
Material Deformation	38	38
Misassembled During Installation	31	31
Leak/Splash	17	17
Misassembled	14	14
Tear, Rip or Hole in Device Packaging	13	13
Noise, Audible	11	11
Mechanical Problem	11	11
Component Missing	11	11
Material Split, Cut or Torn	7	7
Break	7	7
Increase in Pressure	6	6
Component Misassembled	6	6
Packaging Problem	6	6
No Flow	5	5
Fracture	5	5
Detachment of Device or Device Component	5	5
Material Twisted/Bent	4	4
No Apparent Adverse Event	4	4
Loose or Intermittent Connection	3	3
Defective Component	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Contamination	3	3
Difficult to Remove	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Gas/Air Leak	3	3
Infusion or Flow Problem	3	3
Decoupling	3	3
Chemical Problem	2	2
Mechanical Jam	2	2
Connection Problem	2	2
Coagulation in Device or Device Ingredient	2	2
Device Dislodged or Dislocated	2	2
Delivered as Unsterile Product	2	2
Insufficient Flow or Under Infusion	2	2
Improper Flow or Infusion	2	2
Output Problem	2	2
Insufficient Information	2	2
Separation Problem	1	1
Pressure Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Inaccurate Flow Rate	1	1
Compatibility Problem	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	658	658
Hemorrhage/Bleeding	115	115
No Consequences Or Impact To Patient	29	29
Insufficient Information	11	11
Air Embolism	7	7
No Known Impact Or Consequence To Patient	6	6
No Patient Involvement	6	6
Hypovolemia	6	6
Blood Loss	4	4
Death	3	3
Low Oxygen Saturation	3	3
Ischemia	2	2
Bradycardia	2	2
Hypoxia	2	2
Low Blood Pressure/ Hypotension	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Adult Respiratory Distress Syndrome	1	1
Hemolysis	1	1
Embolism/Embolus	1	1
Pericardial Effusion	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

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