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	2
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC PERFUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
QURA S.R.L.
	SUBSTANTIALLY EQUIVALENT	4
SORIN GROUP ITALIA S.R.L
	SUBSTANTIALLY EQUIVALENT	2
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	686	686
Leak/Splash	305	305
Increase in Pressure	205	205
Break	180	180
Material Separation	156	156
Infusion or Flow Problem	154	154
Packaging Problem	120	120
Gas Output Problem	119	119
Obstruction of Flow	106	106
Pressure Problem	103	103
Use of Device Problem	101	101
Crack	94	94
Air/Gas in Device	77	77
Material Deformation	74	74
Coagulation in Device or Device Ingredient	54	54
Adverse Event Without Identified Device or Use Problem	53	53
Insufficient Information	45	45
Defective Component	42	42
Unexpected Therapeutic Results	39	39
Detachment of Device or Device Component	39	39
Failure to Deliver	38	38
Noise, Audible	37	37
Mechanical Problem	36	36
Contamination	34	34
Manufacturing, Packaging or Shipping Problem	33	33
Material Puncture/Hole	32	32
Improper Chemical Reaction	31	31
Insufficient Flow or Under Infusion	30	30
Gas/Air Leak	29	29
Decrease in Pressure	29	29
Shipping Damage or Problem	28	28
Improper Flow or Infusion	24	24
Contamination /Decontamination Problem	23	23
Disconnection	22	22
Connection Problem	21	21
No Flow	19	19
Device Sensing Problem	19	19
Output Problem	16	16
Fracture	15	15
Low Readings	14	14
Medical Gas Supply Problem	14	14
Loose or Intermittent Connection	14	14
Particulates	13	13
Defective Device	13	13
Temperature Problem	13	13
Pumping Stopped	12	12
High Readings	12	12
Scratched Material	12	12
Unable to Obtain Readings	12	12
Device Difficult to Setup or Prepare	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2426	2426
No Patient Involvement	176	176
No Consequences Or Impact To Patient	173	173
Hemorrhage/Bleeding	152	152
Insufficient Information	123	123
No Known Impact Or Consequence To Patient	61	61
Low Oxygen Saturation	50	50
Cardiac Arrest	30	30
Death	26	26
Hypoxia	25	25
Blood Loss	25	25
Low Blood Pressure/ Hypotension	17	17
No Information	17	17
Hemolysis	16	16
Sepsis	13	13
Air Embolism	12	12
Thrombosis/Thrombus	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Stroke/CVA	7	7
Injury	7	7
Unspecified Infection	6	6
Anemia	6	6
Ischemia Stroke	5	5
Respiratory Failure	5	5
Abnormal Blood Gases	5	5
Coagulation Disorder	5	5
Thrombocytopenia	4	4
Bradycardia	4	4
Septic Shock	4	4
Ischemia	4	4
Multiple Organ Failure	3	3
Arrhythmia	3	3
Lactate Dehydrogenase Increased	3	3
Hypothermia	3	3
Thromboembolism	3	3
Renal Failure	3	3
Hypovolemia	2	2
Autoimmune Disorder	2	2
Hematoma	2	2
Exsanguination	2	2
Inflammation	2	2
Bacterial Infection	2	2
Lupus	2	2
Brain Injury	2	2
Asystole	2	2
Swelling/ Edema	2	2
Fistula	1	1
Ventilator Dependent	1	1
Hypersensitivity/Allergic reaction	1	1
Pulmonary Dysfunction	1	1

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	Jan-27-2023
9	Medtronic Perfusion Systems	II	Jul-04-2020
10	Terumo Cardiovascular Systems Corporation	II	Apr-05-2023
11	Terumo Cardiovascular Systems Corporation	II	Dec-14-2020