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	2
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	7
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	546	546
Mechanical Problem	399	399
Material Deformation	382	385
Fluid/Blood Leak	380	384
Material Puncture/Hole	257	258
Delivered as Unsterile Product	245	245
Crack	227	236
Contamination	182	182
Adverse Event Without Identified Device or Use Problem	162	162
Obstruction of Flow	152	153
Break	89	89
Misassembled During Installation	77	77
Air/Gas in Device	61	61
Packaging Problem	61	61
Device Markings/Labelling Problem	55	55
Detachment of Device or Device Component	51	52
Difficult to Open or Close	41	41
Fracture	34	34
Disconnection	30	30
Component Missing	30	30
Leak/Splash	28	28
Insufficient Device Problem Information	25	25
Material Twisted/Bent	21	21
Manufacturing, Packaging or Shipping Problem	18	18
Material Integrity Problem	18	18
Loss of or Failure to Bond	16	16
Material Rupture	13	13
Increase in Pressure	12	12
Material Split, Cut or Torn	12	12
Difficult to Insert	10	10
Use of Device Problem	9	9
Migration	8	8
Partial Blockage	7	7
Particulates	7	7
Nonstandard Device	7	7
Infusion or Flow Problem	7	7
Improper Flow or Infusion	7	7
Deformation Due to Compressive Stress	7	7
Ejection Problem	6	6
Tear, Rip or Hole in Device Packaging	6	6
Contamination /Decontamination Problem	6	6
Device Handling Problem	5	5
Defective Component	5	5
Appropriate Device Problem Term/Code Not Available	5	5
Restricted Flow rate	4	4
Burst Container or Vessel	4	4
Unsealed Device Packaging	4	4
Material Discolored	4	4
Difficult to Open or Remove Packaging Material	4	4
Inflation Problem	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	254	257
Insufficient Information	83	84
No Known Impact Or Consequence To Patient	41	41
Perforation of Vessels	35	35
Stroke/CVA	33	33
Cardiac Arrest	31	31
No Consequences Or Impact To Patient	27	27
Thrombosis/Thrombus	21	21
Foreign Body In Patient	21	21
Low Blood Pressure/ Hypotension	19	19
Air Embolism	19	19
Sepsis	18	18
Hematoma	18	18
Ischemia	18	18
Exsanguination	17	17
Blood Loss	16	16
Death	15	15
Renal Failure	15	15
Vascular Dissection	15	15
Unspecified Infection	13	13
Perforation	12	12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	11	11
Cardiac Perforation	10	10
Atrial Fibrillation	10	10
Swelling/ Edema	9	9
Device Embedded In Tissue or Plaque	9	9
Unspecified Tissue Injury	8	8
Obstruction/Occlusion	8	8
Cardiac Tamponade	8	8
Aortic dissection	8	8
Multiple Organ Dysfunction Syndrome	7	7
Hemolysis	7	7
Respiratory Failure	6	6
Hypoxia	6	6
Pericardial Effusion	5	5
Reduced Blood Flow	5	5
Bradycardia	5	5
Hypovolemia	5	5
No Patient Involvement	5	5
Myocardial Infarction	5	5
Pulmonary Embolism	5	5
Pulmonary Edema	5	5
Ischemia Stroke	5	5
Arrhythmia	5	5
Pneumonia	4	4
Hypovolemic Shock	4	4
Bacterial Infection	4	4
Convulsion/Seizure	4	4
Rupture	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	LivaNova USA Inc.	II	Jun-26-2020
5	Medtronic Perfusion Systems	II	May-20-2026
6	Medtronic Perfusion Systems	I	Sep-03-2025
7	Medtronic Perfusion Systems	I	Mar-13-2025
8	Medtronic Perfusion Systems	II	Jan-17-2025
9	Medtronic Perfusion Systems	II	Nov-04-2024
10	Medtronic Perfusion Systems	II	Sep-12-2024
11	Medtronic Perfusion Systems	II	May-10-2024
12	Medtronic Perfusion Systems	II	Mar-19-2024
13	Medtronic Perfusion Systems	II	Jan-12-2022
14	Medtronic Perfusion Systems	II	Oct-01-2021
15	Medtronic Perfusion Systems	II	Jun-16-2021