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
MEDTRONIC PERFUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	6
QURA S.R.L
	SUBSTANTIALLY EQUIVALENT	4
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	5
SPECTRUM MEDICAL S.R.L.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	1290	1290
Leak/Splash	424	424
Increase in Pressure	363	363
Gas Output Problem	265	265
Break	219	219
Infusion or Flow Problem	202	202
Obstruction of Flow	178	179
Pressure Problem	173	174
Material Separation	162	162
Use of Device Problem	153	153
Crack	135	135
Packaging Problem	130	130
Air/Gas in Device	123	123
Material Deformation	105	105
Coagulation in Device or Device Ingredient	72	72
Delivered as Unsterile Product	69	69
Adverse Event Without Identified Device or Use Problem	68	68
Noise, Audible	66	66
Mechanical Problem	64	64
Material Puncture/Hole	57	57
Unable to Obtain Readings	57	57
Detachment of Device or Device Component	57	57
Insufficient Device Problem Information	57	57
Defective Component	56	56
Unexpected Therapeutic Results	49	49
Failure to Deliver	46	46
Manufacturing, Packaging or Shipping Problem	43	43
Gas/Air Leak	41	42
Device Damaged Prior to Receipt by User	38	38
Contamination	38	38
Improper Flow or Infusion	35	35
Improper Chemical Reaction	35	35
Insufficient Flow or Under Infusion	35	35
Decrease in Pressure	32	33
Fracture	30	30
Contamination /Decontamination Problem	29	29
Device Sensing Problem	29	29
Partial Blockage	28	28
No Flow	25	25
Disconnection	24	24
Connection Problem	24	24
Medical Gas Supply Problem	22	22
Inaccurate Delivery	20	20
Device Difficult to Setup or Prepare	19	19
Defective Device	19	19
Loose or Intermittent Connection	18	18
Particulates	16	16
Device Damaged Prior to Use	16	16
Pumping Stopped	15	15
Temperature Problem	15	15

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3546	3550
No Patient Involvement	321	321
No Consequences Or Impact To Patient	320	320
Hemorrhage/Blood Loss/Bleeding	311	311
No Known Impact Or Consequence To Patient	174	174
Insufficient Information	159	160
Blood Loss	60	60
Low Oxygen Saturation	57	57
No Information	50	50
Death	38	38
Cardiac Arrest	35	35
Hypoxia	34	34
Low Blood Pressure/ Hypotension	25	25
Thrombosis/Thrombus	20	20
Hemolysis	19	19
Sepsis	17	17
Injury	16	16
Coagulation Disorder	14	14
Air Embolism	13	13
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
Respiratory Failure	5	5
Ischemia Stroke	5	5
Pneumonia	5	5
Bradycardia	5	5
Ischemia	5	5
Septic Shock	4	4
Hemodynamic instability	4	4
Asystole	4	4
Tachycardia	4	4
Thrombocytopenia	4	4
Brain Injury	4	4
Thromboembolism	3	3
Lactate Dehydrogenase Increased	3	3
Hematuria	3	3
Multiple Organ Dysfunction Syndrome	3	3
Renal Failure	3	3
Arrhythmia	3	3
Cardiogenic Shock	3	3
Hematoma	3	3
Hypothermia	3	3
Reduced Blood Flow	3	3
Lupus	2	2
Bacterial Infection	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	GETINGE US SALES LLC	II	Dec-12-2019
3	Maquet Cardiovascular Us Sales, Llc	II	Dec-17-2020
4	Maquet Cardiovascular Us Sales, Llc	II	Sep-13-2019
5	Maquet Medical Systems USA	II	Feb-13-2024
6	Maquet Medical Systems USA	II	May-30-2023
7	Maquet Medical Systems USA	II	May-26-2023
8	Maquet Medical Systems USA	II	Feb-28-2023
9	Maquet Medical Systems USA	II	Sep-19-2022
10	Medtronic Perfusion Systems	II	Nov-10-2025
11	Medtronic Perfusion Systems	II	Jan-27-2023
12	Medtronic Perfusion Systems	II	Jul-04-2020
13	Terumo Cardiovascular Systems Corporation	II	Apr-05-2023
14	Terumo Cardiovascular Systems Corporation	II	Dec-14-2020
15	Terumo Cardiovascular Systems Corporation	II	Jul-30-2019