TPLC - Total Product Life Cycle

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Device	catheter, cannula and tubing, vascular, cardiopulmonary bypass
Regulation Description	Cardiopulmonary bypass vascular catheter, cannula, or tubing.
Product Code	DWF
Regulation Number	870.4210
Device Class	2

Premarket Reviews
Manufacturer	Decision
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	3
CARDIOGARD MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	2
KAPP SURGICAL INSTRUMENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIVANOVA USA, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	8
QURA S.R.L
	SUBSTANTIALLY EQUIVALENT	4
SMART REACTORS
	SUBSTANTIALLY EQUIVALENT	1
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	4
SPECTRUM MEDICAL S.R.L.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	554	554
Mechanical Problem	404	404
Fluid/Blood Leak	389	393
Material Deformation	383	386
Material Puncture/Hole	257	258
Delivered as Unsterile Product	247	247
Crack	232	241
Adverse Event Without Identified Device or Use Problem	183	183
Contamination	182	182
Obstruction of Flow	153	154
Break	91	91
Misassembled During Installation	77	77
Air/Gas in Device	61	61
Packaging Problem	61	61
Detachment of Device or Device Component	60	61
Device Markings/Labelling Problem	57	57
Difficult to Open or Close	41	41
Disconnection	41	41
Fracture	36	36
Leak/Splash	32	32
Insufficient Device Problem Information	32	32
Component Missing	30	30
Material Twisted/Bent	26	26
Manufacturing, Packaging or Shipping Problem	19	19
Material Integrity Problem	18	18
Loss of or Failure to Bond	17	17
Material Split, Cut or Torn	16	16
Material Rupture	14	14
Migration	12	12
Increase in Pressure	12	12
Difficult to Insert	10	10
Use of Device Problem	9	9
Defective Component	8	8
Partial Blockage	7	7
Contamination /Decontamination Problem	7	7
Nonstandard Device	7	7
Infusion or Flow Problem	7	7
Improper Flow or Infusion	7	7
Appropriate Device Problem Term/Code Not Available	7	7
Particulates	7	7
Deformation Due to Compressive Stress	7	7
Restricted Flow rate	6	6
Tear, Rip or Hole in Device Packaging	6	6
Ejection Problem	6	6
Device Handling Problem	5	5
Device Contamination with Chemical or Other Material	5	5
Unsealed Device Packaging	5	5
Patient Device Interaction Problem	5	5
No Apparent Adverse Event	4	4
Malposition of Device	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2479	2490
Hemorrhage/Blood Loss/Bleeding	260	263
No Known Impact Or Consequence To Patient	111	111
Insufficient Information	83	84
No Consequences Or Impact To Patient	57	57
Blood Loss	36	37
Perforation of Vessels	36	36
Cardiac Arrest	34	34
Stroke/CVA	34	34
Death	28	28
Foreign Body In Patient	23	23
Low Blood Pressure/ Hypotension	22	22
Air Embolism	22	22
Ischemia	21	21
Thrombosis/Thrombus	21	21
Exsanguination	19	19
Sepsis	18	18
Hematoma	18	18
Vascular Dissection	16	16
Perforation	16	16
Renal Failure	15	15
Cardiac Perforation	14	14
Unspecified Infection	13	13
Cardiac Tamponade	13	13
No Patient Involvement	11	11
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	11	11
Device Embedded In Tissue or Plaque	11	11
Atrial Fibrillation	10	10
Swelling/ Edema	9	9
Unspecified Tissue Injury	8	8
Aortic dissection	8	8
Multiple Organ Dysfunction Syndrome	8	8
Obstruction/Occlusion	8	8
Hemolysis	8	8
Respiratory Failure	7	7
Hypoxia	7	7
Pericardial Effusion	6	6
Hypovolemia	6	6
Bradycardia	6	6
Pulmonary Embolism	6	6
Arrhythmia	6	6
Reduced Blood Flow	5	5
Ischemia Stroke	5	5
Pulmonary Edema	5	5
Laceration(s)	5	5
Rupture	5	5
Myocardial Infarction	5	5
Convulsion/Seizure	4	4
Pneumonia	4	4
Hypovolemic Shock	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardiac Assist, Inc	III	Nov-29-2021
2	Cardiac Assist, Inc	II	Feb-07-2020
3	Edwards Lifesciences, LLC	II	Jan-10-2020
4	Edwards Lifesciences, LLC	II	Nov-18-2019
5	LivaNova USA	II	Jan-23-2019
6	LivaNova USA Inc.	II	Jun-26-2020
7	Maquet Cardiovascular, LLC	II	May-31-2019
8	Medtronic Perfusion Systems	II	May-20-2026
9	Medtronic Perfusion Systems	I	Sep-03-2025
10	Medtronic Perfusion Systems	I	Mar-13-2025
11	Medtronic Perfusion Systems	II	Jan-17-2025
12	Medtronic Perfusion Systems	II	Nov-04-2024
13	Medtronic Perfusion Systems	II	Sep-12-2024
14	Medtronic Perfusion Systems	II	May-10-2024
15	Medtronic Perfusion Systems	II	Mar-19-2024
16	Medtronic Perfusion Systems	II	Jan-12-2022
17	Medtronic Perfusion Systems	II	Oct-01-2021
18	Medtronic Perfusion Systems	II	Jun-16-2021
19	OriGen Biomedical, Inc.	I	Jun-04-2019