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	422
Obstruction of Flow	67	67
Material Separation	66	68
Air/Gas in Device	57	59
Material Puncture/Hole	53	55
Disconnection	46	46
Crack	45	47
Material Deformation	38	38
Misassembled During Installation	31	31
Leak/Splash	17	17
Misassembled	14	15
Tear, Rip or Hole in Device Packaging	13	13
Mechanical Problem	12	12
Noise, Audible	11	11
Component Missing	11	12
Break	8	8
Material Split, Cut or Torn	7	7
Increase in Pressure	6	6
Component Misassembled	6	6
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
Loose or Intermittent Connection	3	3
Decoupling	3	3
Delivered as Unsterile Product	3	3
Infusion or Flow Problem	3	3
Gas/Air Leak	3	3
Device Misassembled During Manufacturing /Shipping	3	3
Difficult to Remove	3	3
Contamination	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Defective Component	3	3
Improper Flow or Infusion	2	2
Insufficient Flow or Under Infusion	2	2
Insufficient Information	2	2
Device Dislodged or Dislocated	2	2
Output Problem	2	2
Coagulation in Device or Device Ingredient	2	2
Connection Problem	2	2
Chemical Problem	2	2
Mechanical Jam	2	2
Contamination /Decontamination Problem	1	1
Device Difficult to Setup or Prepare	1	1
Inaccurate Flow Rate	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Material Integrity Problem	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	662	668
Hemorrhage/Bleeding	115	118
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