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 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	2
QURA S.R.L
	SUBSTANTIALLY EQUIVALENT	4
SORIN GROUP ITALIA S.R.L.
	SUBSTANTIALLY EQUIVALENT	2
SPECTRUM MEDICAL S.R.L.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	1133	1133
Increase in Pressure	311	311
Gas Output Problem	254	254
Leak/Splash	247	247
Break	163	163
Material Separation	161	161
Obstruction of Flow	158	159
Infusion or Flow Problem	134	134
Packaging Problem	126	126
Air/Gas in Device	118	118
Use of Device Problem	110	110
Crack	110	110
Pressure Problem	109	110
Material Deformation	93	93
Delivered as Unsterile Product	66	66
Noise, Audible	62	62
Adverse Event Without Identified Device or Use Problem	56	56
Material Puncture/Hole	51	51
Insufficient Information	50	50
Unexpected Therapeutic Results	47	47
Mechanical Problem	44	44
Contamination	37	37
Coagulation in Device or Device Ingredient	35	35
Gas/Air Leak	35	36
Failure to Deliver	34	34
Shipping Damage or Problem	31	31
Manufacturing, Packaging or Shipping Problem	31	31
Improper Chemical Reaction	30	30
Defective Component	29	29
Decrease in Pressure	25	26
Detachment of Device or Device Component	25	25
Partial Blockage	23	23
Insufficient Flow or Under Infusion	22	22
Device Sensing Problem	19	19
Connection Problem	19	19
Fracture	18	18
Contamination /Decontamination Problem	17	17
Medical Gas Supply Problem	17	17
Disconnection	16	16
Improper Flow or Infusion	15	15
Low Readings	14	14
No Flow	13	13
Output Problem	13	13
Temperature Problem	13	13
Scratched Material	12	12
Pumping Stopped	12	12
Particulates	12	12
Dent in Material	11	11
High Readings	11	11
Defective Device	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3332	3335
Hemorrhage/Bleeding	272	272
Insufficient Information	157	158
No Patient Involvement	66	66
Low Oxygen Saturation	47	47
Cardiac Arrest	34	34
Hypoxia	26	26
Low Blood Pressure/ Hypotension	23	23
Sepsis	17	17
No Consequences Or Impact To Patient	15	15
Hemolysis	15	15
Thrombosis/Thrombus	15	15
Air Embolism	11	11
Coagulation Disorder	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Anemia	9	9
Unspecified Infection	8	8
Stroke/CVA	7	7
Ischemia Stroke	5	5
Respiratory Failure	5	5
Ischemia	5	5
Pneumonia	5	5
Death	4	4
Abnormal Blood Gases	4	4
Tachycardia	4	4
Asystole	4	4
Bradycardia	4	4
No Known Impact Or Consequence To Patient	4	4
Thrombocytopenia	3	3
Renal Failure	3	3
Hypothermia	3	3
Cardiogenic Shock	3	3
Septic Shock	3	3
Arrhythmia	3	3
Multiple Organ Failure	3	3
Brain Injury	3	3
Cardiac Tamponade	2	2
Ventricular Fibrillation	2	2
Hypovolemia	2	2
Apnea	2	2
Ventilator Dependent	2	2
Asthma	2	2
Lactate Dehydrogenase Increased	2	2
Bacterial Infection	2	2
Hematoma	2	2
Exsanguination	2	2
Swelling/ Edema	2	2
Unspecified Respiratory Problem	2	2
Myocardial Infarction	2	2
Fistula	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