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
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	3
SPECTRUM MEDICAL S.R.L.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	531	531
Mechanical Problem	388	388
Material Deformation	380	383
Fluid/Blood Leak	308	312
Material Puncture/Hole	241	242
Delivered as Unsterile Product	240	240
Crack	233	242
Contamination	180	180
Obstruction of Flow	154	155
Adverse Event Without Identified Device or Use Problem	139	139
Break	83	83
Misassembled During Installation	76	76
Air/Gas in Device	61	61
Packaging Problem	59	59
Device Markings/Labelling Problem	55	55
Detachment of Device or Device Component	44	45
Difficult to Open or Close	40	40
Fracture	34	34
Component Missing	30	30
Leak/Splash	28	28
Insufficient Information	24	24
Manufacturing, Packaging or Shipping Problem	20	20
Disconnection	19	19
Material Twisted/Bent	19	19
Loss of or Failure to Bond	15	15
Material Integrity Problem	15	15
Material Rupture	14	14
Increase in Pressure	11	11
Material Split, Cut or Torn	10	10
Infusion or Flow Problem	9	9
Partial Blockage	9	9
Nonstandard Device	8	8
Difficult to Insert	8	8
Migration	8	8
Use of Device Problem	8	8
Particulates	7	7
Defective Component	6	6
Physical Resistance/Sticking	6	6
Tear, Rip or Hole in Device Packaging	6	6
Positioning Problem	5	5
Appropriate Term/Code Not Available	5	5
Deformation Due to Compressive Stress	5	5
No Flow	5	5
Unsealed Device Packaging	4	4
Contamination /Decontamination Problem	4	4
Ejection Problem	4	4
Restricted Flow rate	4	4
Difficult to Open or Remove Packaging Material	4	4
Malposition of Device	4	4
Inflation Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2374	2385
Hemorrhage/Bleeding	233	236
Insufficient Information	80	80
Stroke/CVA	32	32
Perforation of Vessels	31	31
Cardiac Arrest	25	25
Thrombosis/Thrombus	20	20
Foreign Body In Patient	19	19
Air Embolism	17	17
Exsanguination	17	17
Hematoma	17	17
Low Blood Pressure/ Hypotension	16	16
Renal Failure	15	15
Sepsis	15	15
Ischemia	15	15
Vascular Dissection	14	14
Unspecified Infection	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Perforation	11	11
Atrial Fibrillation	10	10
Swelling/ Edema	9	9
Device Embedded In Tissue or Plaque	8	8
Unspecified Tissue Injury	8	8
Obstruction/Occlusion	8	8
Cardiac Perforation	7	7
Pulmonary Edema	6	6
Multiple Organ Failure	6	6
Cardiac Tamponade	5	5
Pericardial Effusion	5	5
Myocardial Infarction	5	5
Hemolysis	5	5
Respiratory Failure	5	5
Ischemia Stroke	5	5
Convulsion/Seizure	4	4
Tricuspid Valve Insufficiency/ Regurgitation	4	4
Bacterial Infection	4	4
Pneumonia	4	4
Pulmonary Embolism	4	4
Cardiogenic Shock	4	4
Arrhythmia	4	4
Hypovolemia	4	4
Hypovolemic Shock	4	4
Pleural Effusion	4	4
Hypoxia	3	3
Thrombocytopenia	3	3
Tachycardia	3	3
Asystole	3	3
Decreased Respiratory Rate	3	3
Bradycardia	3	3
Laceration(s)	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardiac Assist, Inc	III	Nov-29-2021
2	Medtronic Perfusion Systems	II	May-20-2026
3	Medtronic Perfusion Systems	I	Sep-03-2025
4	Medtronic Perfusion Systems	I	Mar-13-2025
5	Medtronic Perfusion Systems	II	Jan-17-2025
6	Medtronic Perfusion Systems	II	Nov-04-2024
7	Medtronic Perfusion Systems	II	Sep-12-2024
8	Medtronic Perfusion Systems	II	May-10-2024
9	Medtronic Perfusion Systems	II	Mar-19-2024
10	Medtronic Perfusion Systems	II	Jan-12-2022
11	Medtronic Perfusion Systems	II	Oct-01-2021
12	Medtronic Perfusion Systems	II	Jun-16-2021