TPLC - Total Product Life Cycle

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Device	oxygenator, cardiopulmonary bypass
Regulation Description	Cardiopulmonary bypass oxygenator.
Product Code	DTZ
Regulation Number	870.4350
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	1
ABIOMED, INC.
	SUBSTANTIALLY EQUIVALENT	2
CHALICE MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	3
EUROSETS S.R.L
	SUBSTANTIALLY EQUIVALENT	4
LIFEMOTION MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	1
1. K230640 Affinity Fusion™ Oxygenator System
2. K241352 Affinity NT Oxygenator and Uncoated Cardiotomy/ Ve ...
MEDTRONIC PERFUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
1. K230640 Affinity Fusion™ Oxygenator System
2. K241352 Affinity NT Oxygenator and Uncoated Cardiotomy/ Ve ...
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
Fluid/Blood Leak	1252	1252
Increase in Pressure	347	347
Leak/Splash	343	343
Gas Output Problem	265	265
Break	186	186
Obstruction of Flow	172	173
Infusion or Flow Problem	169	169
Material Separation	162	162
Pressure Problem	151	152
Use of Device Problem	130	130
Packaging Problem	130	130
Crack	128	128
Air/Gas in Device	123	123
Material Deformation	100	100
Delivered as Unsterile Product	69	69
Adverse Event Without Identified Device or Use Problem	66	66
Noise, Audible	66	66
Mechanical Problem	64	64
Coagulation in Device or Device Ingredient	58	58
Material Puncture/Hole	57	57
Insufficient Device Problem Information	55	55
Unexpected Therapeutic Results	49	49
Failure to Deliver	46	46
Defective Component	42	42
Gas/Air Leak	41	42
Detachment of Device or Device Component	40	40
Contamination	38	38
Improper Chemical Reaction	35	35
Manufacturing, Packaging or Shipping Problem	34	34
Device Damaged Prior to Receipt by User	32	32
Decrease in Pressure	32	33
Insufficient Flow or Under Infusion	30	30
Improper Flow or Infusion	29	29
Contamination /Decontamination Problem	27	27
Connection Problem	24	24
Disconnection	23	23
Partial Blockage	23	23
Fracture	22	22
No Flow	20	20
Medical Gas Supply Problem	20	20
Device Sensing Problem	19	19
Temperature Problem	15	15
Pumping Stopped	15	15
Defective Device	15	15
Loose or Intermittent Connection	14	14
Low Readings	14	14
Output Problem	13	13
Particulates	13	13
Scratched Material	12	12
Unable to Obtain Readings	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3546	3550
Hemorrhage/Blood Loss/Bleeding	311	311
No Patient Involvement	176	176
No Consequences Or Impact To Patient	173	173
Insufficient Information	159	160
No Known Impact Or Consequence To Patient	61	61
Low Oxygen Saturation	56	56
Cardiac Arrest	34	34
Hypoxia	34	34
Death	26	26
Blood Loss	25	25
Low Blood Pressure/ Hypotension	24	24
Thrombosis/Thrombus	20	20
Hemolysis	18	18
Sepsis	17	17
No Information	17	17
Coagulation Disorder	14	14
Air Embolism	12	12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	11	11
Abnormal Blood Gases	9	9
Anemia	9	9
Unspecified Infection	8	8
Stroke/CVA	8	8
Injury	7	7
Ischemia Stroke	5	5
Respiratory Failure	5	5
Ischemia	5	5
Pneumonia	5	5
Thrombocytopenia	4	4
Tachycardia	4	4
Bradycardia	4	4
Hemodynamic instability	4	4
Septic Shock	4	4
Brain Injury	4	4
Asystole	4	4
Thromboembolism	3	3
Lactate Dehydrogenase Increased	3	3
Hypothermia	3	3
Multiple Organ Dysfunction Syndrome	3	3
Renal Failure	3	3
Arrhythmia	3	3
Cardiogenic Shock	3	3
Hematoma	3	3
Hematuria	3	3
Reduced Blood Flow	3	3
Lupus	2	2
Swelling/ Edema	2	2
Autoimmune Disorder	2	2
Ventricular Fibrillation	2	2
Disseminated Intravascular Coagulation (DIC)	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Abiomed, Inc.	I	Feb-03-2022
2	Maquet Cardiovascular Us Sales, Llc	II	Dec-17-2020
3	Maquet Medical Systems USA	II	Feb-13-2024
4	Maquet Medical Systems USA	II	May-30-2023
5	Maquet Medical Systems USA	II	May-26-2023
6	Maquet Medical Systems USA	II	Feb-28-2023
7	Maquet Medical Systems USA	II	Sep-19-2022
8	Medtronic Perfusion Systems	II	Nov-10-2025
9	Medtronic Perfusion Systems	II	Jan-27-2023
10	Medtronic Perfusion Systems	II	Jul-04-2020
11	Terumo Cardiovascular Systems Corporation	II	Apr-05-2023
12	Terumo Cardiovascular Systems Corporation	II	Dec-14-2020