TPLC - Total Product Life Cycle

show TPLC since

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	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	5
QURA S.R.L
	SUBSTANTIALLY EQUIVALENT	4
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	474	474
Mechanical Problem	363	363
Material Deformation	344	347
Fluid/Blood Leak	245	249
Crack	231	240
Material Puncture/Hole	188	189
Contamination	174	174
Adverse Event Without Identified Device or Use Problem	153	153
Delivered as Unsterile Product	142	142
Obstruction of Flow	139	141
Break	78	78
Misassembled During Installation	71	71
Air/Gas in Device	53	53
Device Markings/Labelling Problem	49	49
Packaging Problem	49	49
Detachment of Device or Device Component	48	49
Fracture	39	39
Difficult to Open or Close	35	35
Leak/Splash	33	33
Disconnection	33	33
Insufficient Information	25	25
Material Twisted/Bent	20	20
Manufacturing, Packaging or Shipping Problem	20	20
Component Missing	19	19
Loss of or Failure to Bond	17	17
Material Split, Cut or Torn	15	15
Material Rupture	14	14
Material Integrity Problem	14	14
Nonstandard Device	11	11
Difficult to Insert	10	10
Increase in Pressure	9	9
Migration	9	9
Gas/Air Leak	8	8
Improper Flow or Infusion	8	8
Deformation Due to Compressive Stress	7	7
Partial Blockage	7	7
No Flow	7	7
Use of Device Problem	7	7
Tear, Rip or Hole in Device Packaging	6	6
Ejection Problem	6	6
Physical Resistance/Sticking	6	6
Infusion or Flow Problem	6	6
Particulates	6	6
Inflation Problem	5	5
Positioning Problem	5	5
Coagulation in Device or Device Ingredient	5	6
Loose or Intermittent Connection	5	5
Appropriate Term/Code Not Available	5	5
Device Handling Problem	5	5
Defective Device	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2062	2073
Hemorrhage/Bleeding	195	198
Insufficient Information	69	70
No Known Impact Or Consequence To Patient	41	41
Perforation of Vessels	29	29
Cardiac Arrest	29	29
No Consequences Or Impact To Patient	27	27
Stroke/CVA	26	26
Thrombosis/Thrombus	20	20
Foreign Body In Patient	20	20
Low Blood Pressure/ Hypotension	19	19
Air Embolism	18	18
Hematoma	18	18
Exsanguination	17	17
Blood Loss	16	16
Death	15	15
Renal Failure	15	15
Sepsis	13	13
Ischemia	12	12
Vascular Dissection	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Unspecified Infection	11	11
Perforation	11	11
Atrial Fibrillation	10	10
Cardiac Perforation	10	10
Swelling/ Edema	9	9
Device Embedded In Tissue or Plaque	9	9
Cardiac Tamponade	8	8
Obstruction/Occlusion	8	8
Unspecified Tissue Injury	7	7
Hemolysis	7	7
Respiratory Failure	6	6
Ischemia Stroke	5	5
No Patient Involvement	5	5
Bradycardia	5	5
Hypovolemia	5	5
Arrhythmia	5	5
Pericardial Effusion	5	5
Pulmonary Embolism	5	5
Myocardial Infarction	5	5
Bacterial Infection	4	4
Pneumonia	4	4
Pleural Effusion	4	4
Cardiogenic Shock	4	4
Rupture	4	4
Tricuspid Valve Insufficiency/ Regurgitation	4	4
Decreased Respiratory Rate	4	4
Pulmonary Edema	4	4
Brain Injury	4	4
Bronchopneumonia	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	I	Sep-03-2025
6	Medtronic Perfusion Systems	I	Mar-13-2025
7	Medtronic Perfusion Systems	II	Jan-17-2025
8	Medtronic Perfusion Systems	II	Nov-04-2024
9	Medtronic Perfusion Systems	II	Sep-12-2024
10	Medtronic Perfusion Systems	II	May-10-2024
11	Medtronic Perfusion Systems	II	Mar-19-2024
12	Medtronic Perfusion Systems	II	Jan-12-2022
13	Medtronic Perfusion Systems	II	Oct-01-2021
14	Medtronic Perfusion Systems	II	Jun-16-2021