TPLC - Total Product Life Cycle

show TPLC since

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	1229	1229
Increase in Pressure	327	327
Gas Output Problem	261	261
Leak/Splash	251	251
Break	163	163
Obstruction of Flow	163	164
Material Separation	161	161
Infusion or Flow Problem	132	132
Packaging Problem	127	127
Air/Gas in Device	122	122
Crack	119	119
Use of Device Problem	116	116
Pressure Problem	116	117
Material Deformation	96	96
Delivered as Unsterile Product	69	69
Noise, Audible	65	65
Adverse Event Without Identified Device or Use Problem	58	58
Material Puncture/Hole	57	57
Insufficient Device Problem Information	51	51
Mechanical Problem	50	50
Unexpected Therapeutic Results	49	49
Gas/Air Leak	38	39
Contamination	38	38
Failure to Deliver	35	35
Coagulation in Device or Device Ingredient	35	35
Improper Chemical Reaction	31	31
Manufacturing, Packaging or Shipping Problem	31	31
Device Damaged Prior to Receipt by User	31	31
Defective Component	28	28
Decrease in Pressure	26	27
Detachment of Device or Device Component	23	23
Partial Blockage	23	23
Insufficient Flow or Under Infusion	22	22
Connection Problem	21	21
Fracture	20	20
Device Sensing Problem	19	19
Contamination /Decontamination Problem	19	19
Medical Gas Supply Problem	17	17
Disconnection	16	16
Improper Flow or Infusion	15	15
No Flow	14	14
Pumping Stopped	14	14
Low Readings	14	14
Temperature Problem	13	13
Scratched Material	12	12
Particulates	12	12
Complete Blockage	11	11
High Readings	11	11
Dent in Material	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	3484	3487
Hemorrhage/Blood Loss/Bleeding	309	309
Insufficient Information	157	158
No Patient Involvement	66	66
Low Oxygen Saturation	47	47
Cardiac Arrest	34	34
Hypoxia	27	27
Low Blood Pressure/ Hypotension	24	24
Thrombosis/Thrombus	19	19
Hemolysis	17	17
Sepsis	17	17
No Consequences Or Impact To Patient	15	15
Coagulation Disorder	14	14
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	11	11
Air Embolism	11	11
Anemia	9	9
Unspecified Infection	8	8
Stroke/CVA	7	7
Respiratory Failure	5	5
Ischemia Stroke	5	5
Pneumonia	5	5
Abnormal Blood Gases	5	5
Ischemia	5	5
Asystole	4	4
Tachycardia	4	4
Bradycardia	4	4
No Known Impact Or Consequence To Patient	4	4
Death	4	4
Hemodynamic instability	4	4
Renal Failure	3	3
Septic Shock	3	3
Hypothermia	3	3
Brain Injury	3	3
Hematoma	3	3
Multiple Organ Dysfunction Syndrome	3	3
Cardiogenic Shock	3	3
Arrhythmia	3	3
Reduced Blood Flow	3	3
Thrombocytopenia	3	3
Apnea	2	2
Unspecified Respiratory Problem	2	2
Ventricular Fibrillation	2	2
Lactate Dehydrogenase Increased	2	2
Hypovolemia	2	2
Disseminated Intravascular Coagulation (DIC)	2	2
Decreased Level of Consciousness	2	2
Ventilator Dependent	2	2
Bacterial Infection	2	2
Asthma	2	2
Exsanguination	2	2

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