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
1. K203111 Affinity Fusion Oxygenator System, Affinity Pixie ...
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	612	612
Leak/Splash	299	299
Break	179	179
Increase in Pressure	168	168
Material Separation	156	156
Infusion or Flow Problem	148	148
Packaging Problem	118	118
Gas Output Problem	98	98
Use of Device Problem	97	97
Pressure Problem	93	93
Crack	91	91
Obstruction of Flow	89	89
Air/Gas in Device	71	71
Material Deformation	68	68
Coagulation in Device or Device Ingredient	53	53
Adverse Event Without Identified Device or Use Problem	48	48
Insufficient Information	43	43
Defective Component	42	42
Detachment of Device or Device Component	39	39
Noise, Audible	34	34
Mechanical Problem	34	34
Contamination	34	34
Unexpected Therapeutic Results	33	33
Failure to Deliver	32	32
Material Puncture/Hole	32	32
Manufacturing, Packaging or Shipping Problem	31	31
Improper Chemical Reaction	30	30
Insufficient Flow or Under Infusion	30	30
Decrease in Pressure	29	29
Shipping Damage or Problem	28	28
Gas/Air Leak	27	27
Improper Flow or Infusion	24	24
Disconnection	22	22
Contamination /Decontamination Problem	21	21
Connection Problem	20	20
Device Sensing Problem	19	19
No Flow	19	19
Fracture	15	15
Output Problem	15	15
Low Readings	14	14
Medical Gas Supply Problem	14	14
Particulates	13	13
Loose or Intermittent Connection	13	13
Scratched Material	12	12
High Readings	12	12
Temperature Problem	12	12
Unable to Obtain Readings	12	12
Pumping Stopped	12	12
Defective Device	12	12
Device Contamination with Chemical or Other Material	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2256	2256
No Patient Involvement	176	176
No Consequences Or Impact To Patient	173	173
Hemorrhage/Bleeding	134	134
Insufficient Information	112	112
No Known Impact Or Consequence To Patient	61	61
Low Oxygen Saturation	48	48
Cardiac Arrest	27	27
Death	26	26
Hypoxia	25	25
Blood Loss	25	25
No Information	17	17
Low Blood Pressure/ Hypotension	14	14
Sepsis	13	13
Air Embolism	12	12
Hemolysis	12	12
Thrombosis/Thrombus	10	10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Stroke/CVA	7	7
Injury	7	7
Unspecified Infection	6	6
Anemia	6	6
Ischemia Stroke	5	5
Abnormal Blood Gases	5	5
Coagulation Disorder	5	5
Respiratory Failure	4	4
Thrombocytopenia	4	4
Bradycardia	4	4
Thromboembolism	3	3
Ischemia	3	3
Lactate Dehydrogenase Increased	3	3
Multiple Organ Failure	3	3
Hypothermia	3	3
Hypovolemia	2	2
Swelling/ Edema	2	2
Renal Failure	2	2
Asystole	2	2
Septic Shock	2	2
Arrhythmia	2	2
Autoimmune Disorder	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

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