TPLC - Total Product Life Cycle

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Device	oxygenator, cardiopulmonary bypass
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	533	533
Leak/Splash	292	292
Break	176	176
Material Separation	153	153
Increase in Pressure	149	149
Infusion or Flow Problem	141	141
Packaging Problem	117	117
Gas Output Problem	89	89
Pressure Problem	89	89
Use of Device Problem	89	89
Crack	86	86
Obstruction of Flow	86	86
Material Deformation	61	61
Air/Gas in Device	59	59
Coagulation in Device or Device Ingredient	53	53
Adverse Event Without Identified Device or Use Problem	46	46
Insufficient Information	42	42
Defective Component	42	42
Detachment of Device or Device Component	39	39
Contamination	34	34
Unexpected Therapeutic Results	31	31
Material Puncture/Hole	31	31
Manufacturing, Packaging or Shipping Problem	31	31
Mechanical Problem	30	30
Noise, Audible	29	29
Improper Chemical Reaction	28	28
Insufficient Flow or Under Infusion	28	28
Shipping Damage or Problem	28	28
Decrease in Pressure	27	27
Failure to Deliver	27	27
Gas/Air Leak	26	26
Improper Flow or Infusion	24	24
Disconnection	22	22
Connection Problem	20	20
No Flow	19	19
Device Sensing Problem	19	19
Contamination /Decontamination Problem	16	16
Output Problem	15	15
Medical Gas Supply Problem	14	14
Fracture	13	13
Low Readings	13	13
Particulates	13	13
Defective Device	12	12
Temperature Problem	12	12
Pumping Stopped	12	12
Loose or Intermittent Connection	12	12
Scratched Material	12	12
Unable to Obtain Readings	12	12
High Readings	11	11
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	2104	2104
No Patient Involvement	176	176
No Consequences Or Impact To Patient	173	173
Hemorrhage/Bleeding	116	116
Insufficient Information	101	101
No Known Impact Or Consequence To Patient	61	61
Low Oxygen Saturation	43	43
Death	26	26
Blood Loss	25	25
Hypoxia	24	24
Cardiac Arrest	23	23
No Information	17	17
Low Blood Pressure/ Hypotension	14	14
Sepsis	13	13
Air Embolism	11	11
Hemolysis	10	10
Thrombosis/Thrombus	8	8
Injury	7	7
Unspecified Infection	6	6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	6	6
Stroke/CVA	6	6
Anemia	6	6
Ischemia Stroke	5	5
Abnormal Blood Gases	5	5
Respiratory Failure	4	4
Thrombocytopenia	4	4
Coagulation Disorder	4	4
Bradycardia	4	4
Thromboembolism	3	3
Ischemia	3	3
Lactate Dehydrogenase Increased	3	3
Hypothermia	3	3
Multiple Organ Failure	3	3
Hypovolemia	2	2
Swelling/ Edema	2	2
Asystole	2	2
Septic Shock	2	2
Autoimmune Disorder	2	2
Arrhythmia	2	2
Lupus	2	2
Brain Injury	2	2
Inflammation	2	2
Hematoma	2	2
Exsanguination	2	2
Fistula	1	1
Thrombus	1	1
Hypersensitivity/Allergic reaction	1	1
Hypoventilation	1	1
Pulmonary Dysfunction	1	1
Respiratory Insufficiency	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