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	396	396
Obstruction of Flow	65	65
Material Separation	56	56
Air/Gas in Device	53	53
Material Puncture/Hole	50	50
Disconnection	43	43
Crack	40	40
Material Deformation	35	35
Misassembled During Installation	28	28
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	10	10
Material Split, Cut or Torn	7	7
Break	7	7
No Flow	5	5
Increase in Pressure	5	5
Fracture	5	5
Detachment of Device or Device Component	5	5
Packaging Problem	5	5
Component Misassembled	4	4
Material Twisted/Bent	4	4
Defective Component	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Contamination	3	3
Difficult to Remove	3	3
Loose or Intermittent Connection	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
Separation Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Product Quality Problem	1	1
Pressure Problem	1	1
Inaccurate Flow Rate	1	1
Free or Unrestricted Flow	1	1
No Apparent Adverse Event	1	1
Entrapment of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	627	627
Hemorrhage/Bleeding	105	105
No Consequences Or Impact To Patient	29	29
Insufficient Information	10	10
No Known Impact Or Consequence To Patient	6	6
No Patient Involvement	6	6
Hypovolemia	6	6
Air Embolism	4	4
Blood Loss	4	4
Death	3	3
Low Oxygen Saturation	3	3
Ischemia	2	2
Bradycardia	2	2
Hypoxia	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	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
Low Blood Pressure/ Hypotension	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