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	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	6
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	525	525
Mechanical Problem	380	380
Material Deformation	364	367
Fluid/Blood Leak	260	264
Crack	234	243
Delivered as Unsterile Product	225	225
Material Puncture/Hole	194	195
Contamination	178	178
Adverse Event Without Identified Device or Use Problem	157	157
Obstruction of Flow	143	145
Break	85	85
Misassembled During Installation	74	74
Air/Gas in Device	59	59
Packaging Problem	57	57
Device Markings/Labelling Problem	53	53
Detachment of Device or Device Component	50	51
Fracture	40	40
Difficult to Open or Close	37	37
Disconnection	33	33
Leak/Splash	33	33
Component Missing	27	27
Insufficient Information	25	25
Manufacturing, Packaging or Shipping Problem	20	20
Material Twisted/Bent	20	20
Material Integrity Problem	18	18
Loss of or Failure to Bond	17	17
Material Split, Cut or Torn	16	16
Material Rupture	14	14
Nonstandard Device	11	11
Increase in Pressure	10	10
Difficult to Insert	10	10
Migration	9	9
Deformation Due to Compressive Stress	8	8
Improper Flow or Infusion	8	8
Gas/Air Leak	8	8
Use of Device Problem	8	8
No Flow	7	7
Partial Blockage	7	7
Physical Resistance/Sticking	6	6
Tear, Rip or Hole in Device Packaging	6	6
Contamination /Decontamination Problem	6	6
Infusion or Flow Problem	6	6
Particulates	6	6
Ejection Problem	6	6
Loose or Intermittent Connection	5	5
Coagulation in Device or Device Ingredient	5	6
Appropriate Term/Code Not Available	5	5
Defective Device	5	5
Positioning Problem	5	5
Device Handling Problem	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2235	2246
Hemorrhage/Bleeding	204	207
Insufficient Information	76	77
No Known Impact Or Consequence To Patient	41	41
Perforation of Vessels	32	32
Cardiac Arrest	29	29
Stroke/CVA	28	28
No Consequences Or Impact To Patient	27	27
Foreign Body In Patient	21	21
Thrombosis/Thrombus	20	20
Air Embolism	19	19
Low Blood Pressure/ Hypotension	19	19
Hematoma	18	18
Exsanguination	17	17
Blood Loss	16	16
Renal Failure	15	15
Death	15	15
Vascular Dissection	14	14
Ischemia	14	14
Sepsis	13	13
Unspecified Infection	13	13
Perforation	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Cardiac Perforation	10	10
Atrial Fibrillation	10	10
Device Embedded In Tissue or Plaque	9	9
Swelling/ Edema	9	9
Cardiac Tamponade	8	8
Obstruction/Occlusion	8	8
Hemolysis	7	7
Unspecified Tissue Injury	7	7
Respiratory Failure	6	6
Hypoxia	6	6
Hypovolemia	5	5
No Patient Involvement	5	5
Ischemia Stroke	5	5
Arrhythmia	5	5
Myocardial Infarction	5	5
Pulmonary Embolism	5	5
Bradycardia	5	5
Pericardial Effusion	5	5
Bacterial Infection	4	4
Pleural Effusion	4	4
Pneumonia	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

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