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	1
CHALICE MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
EUROSETS SRL
	SUBSTANTIALLY EQUIVALENT	4
MEDTRONIC
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC PERFUSION SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
QURA S.R.L
	SUBSTANTIALLY EQUIVALENT	4
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	912	912
Increase in Pressure	275	275
Leak/Splash	227	227
Gas Output Problem	209	209
Break	159	159
Material Separation	157	157
Obstruction of Flow	131	132
Infusion or Flow Problem	127	127
Packaging Problem	120	120
Use of Device Problem	106	106
Crack	101	101
Air/Gas in Device	99	99
Pressure Problem	95	96
Material Deformation	86	86
Noise, Audible	48	48
Adverse Event Without Identified Device or Use Problem	48	48
Unexpected Therapeutic Results	45	45
Insufficient Information	43	43
Material Puncture/Hole	39	39
Mechanical Problem	35	35
Coagulation in Device or Device Ingredient	34	34
Contamination	34	34
Manufacturing, Packaging or Shipping Problem	31	31
Shipping Damage or Problem	31	31
Gas/Air Leak	30	31
Defective Component	29	29
Improper Chemical Reaction	28	28
Failure to Deliver	27	27
Decrease in Pressure	25	26
Detachment of Device or Device Component	23	23
Insufficient Flow or Under Infusion	22	22
Device Sensing Problem	19	19
Connection Problem	18	18
Fracture	17	17
Partial Blockage	17	17
Contamination /Decontamination Problem	17	17
Disconnection	15	15
Low Readings	14	14
Improper Flow or Infusion	14	14
Output Problem	13	13
No Flow	13	13
Particulates	12	12
Pumping Stopped	12	12
Scratched Material	12	12
Temperature Problem	12	12
Medical Gas Supply Problem	11	11
Dent in Material	11	11
High Readings	11	11
Defective Device	11	11
Unable to Obtain Readings	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2899	2902
Hemorrhage/Bleeding	221	221
Insufficient Information	140	141
No Patient Involvement	66	66
Low Oxygen Saturation	46	46
Cardiac Arrest	32	32
Low Blood Pressure/ Hypotension	22	22
Hypoxia	20	20
Sepsis	16	16
Hemolysis	15	15
No Consequences Or Impact To Patient	15	15
Thrombosis/Thrombus	13	13
Air Embolism	11	11
Anemia	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Unspecified Infection	7	7
Stroke/CVA	6	6
Coagulation Disorder	6	6
Ischemia Stroke	5	5
Respiratory Failure	5	5
Pneumonia	5	5
Death	4	4
Ischemia	4	4
Tachycardia	4	4
Asystole	4	4
Bradycardia	4	4
No Known Impact Or Consequence To Patient	4	4
Arrhythmia	3	3
Thrombocytopenia	3	3
Multiple Organ Failure	3	3
Renal Failure	3	3
Hypothermia	3	3
Septic Shock	3	3
Cardiogenic Shock	3	3
Hypovolemia	2	2
Ventilator Dependent	2	2
Bacterial Infection	2	2
Myocardial Infarction	2	2
Swelling/ Edema	2	2
Lactate Dehydrogenase Increased	2	2
Ventricular Fibrillation	2	2
Asthma	2	2
Hematoma	2	2
Exsanguination	2	2
Abnormal Blood Gases	2	2
Apnea	2	2
Foreign Body In Patient	1	1
Exposure to Body Fluids	1	1
Injury	1	1
Disseminated Intravascular Coagulation (DIC)	1	1

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