TPLC - Total Product Life Cycle

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Device	console, heart-lung machine, cardiopulmonary bypass
Regulation Description	Cardiopulmonary bypass heart-lung machine console.
Product Code	DTQ
Regulation Number	870.4220
Device Class	2

Premarket Reviews
Manufacturer	Decision
CENTURY HLM, LLC
	SUBSTANTIALLY EQUIVALENT	1
LIVANOVA DEUTSCHLAND, GMBH
	SUBSTANTIALLY EQUIVALENT	3
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output Problem	570	570
Pumping Problem	540	551
Pumping Stopped	509	525
Device Alarm System	251	251
Difficult to Open or Close	247	247
Display or Visual Feedback Problem	247	247
Pressure Problem	200	200
Mechanical Problem	183	185
Incorrect, Inadequate or Imprecise Result or Readings	137	137
Calibration Problem	130	130
Device Sensing Problem	129	130
Infusion or Flow Problem	124	126
Failure to Calibrate	112	112
Communication or Transmission Problem	112	113
Failure to Read Input Signal	105	105
Power Problem	102	102
Electrical /Electronic Property Problem	100	100
Battery Problem	77	78
Charging Problem	74	74
Break	73	73
Application Program Problem	66	66
Inadequate User Interface	62	62
No Display/Image	61	61
Failure to Pump	57	57
Failure to Power Up	45	45
Insufficient Device Problem Information	44	44
Low Readings	43	44
Unintended Movement	42	73
Adverse Event Without Identified Device or Use Problem	38	38
False Alarm	38	38
Connection Problem	37	37
Unexpected Shutdown	35	35
No Flow	33	33
Crack	30	30
Unable to Obtain Readings	27	27
Mechanical Jam	23	23
Defective Alarm	22	22
Decoupling	21	21
Material Deformation	21	21
Noise, Audible	21	22
Failure to Auto Stop	20	20
Improper Flow or Infusion	20	20
Unstable	19	19
Computer Software Problem	18	18
Increase in Pressure	17	17
Incorrect Measurement	17	17
Detachment of Device or Device Component	14	14
Intermittent Communication Failure	13	13
Overheating of Device	13	13
Application Program Freezes or Fails to Launch	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4331	4392
Insufficient Information	308	308
Cardiac Arrest	44	44
No Consequences Or Impact To Patient	27	27
No Patient Involvement	21	21
Hemorrhage/Blood Loss/Bleeding	18	18
Air Embolism	10	10
Arrhythmia	8	8
Low Oxygen Saturation	8	8
No Known Impact Or Consequence To Patient	8	8
Low Blood Pressure/ Hypotension	7	7
Brain Injury	6	6
Ischemia Stroke	6	6
Asystole	6	6
Bronchial Hemorrhage	4	4
Bone Fracture(s)	4	4
Exsanguination	4	4
Hemodynamic instability	3	3
Hypoxia	3	3
Thrombosis/Thrombus	3	3
Pulmonary Edema	3	3
Hemolysis	3	3
Airway Obstruction	2	2
Valvular Stenosis	2	2
Bradycardia	2	2
Hematoma	2	2
Tachycardia	2	2
Aneurysm	2	2
Embolism/Embolus	2	2
Cardiovascular Dysfunction/Insufficiency	2	2
Sepsis	2	2
Myocarditis	2	2
Hemothorax	2	2
Septic Shock	2	2
Heart Failure/Congestive Heart Failure	2	2
Respiratory Arrest	2	2
Ischemia	2	2
Endocarditis	2	2
Nervous System Injury	2	2
Intracranial Hemorrhage	2	2
Burn(s)	2	2
Multiple Organ Dysfunction Syndrome	2	2
Hemolytic Anemia	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Low Cardiac Output	1	1
Bacterial Infection	1	1
Shock from Patient Lead(s)	1	1
Reduced Blood Flow	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	LivaNova Deutschland GmbH	II	Nov-27-2024
2	Maquet Cardiopulmonary Ag	II	May-27-2025
3	Maquet Cardiopulmonary Gmbh	II	Feb-05-2026
4	Maquet Medical Systems USA	III	Sep-30-2024
5	Maquet Medical Systems USA	II	May-16-2024
6	Maquet Medical Systems USA	II	Feb-08-2024
7	Maquet Medical Systems USA	II	Dec-21-2023
8	Maquet Medical Systems USA	II	Dec-14-2023
9	Maquet Medical Systems USA	I	Dec-07-2023
10	Maquet Medical Systems USA	II	Nov-09-2023
11	Maquet Medical Systems USA	II	May-26-2023
12	Maquet Medical Systems USA	II	Apr-08-2022
13	Spectrum Medical Ltd.	II	Oct-24-2024
14	Terumo Cardiovascular Systems Corporation	II	Aug-26-2021