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	538	538
Pumping Problem	502	513
Pumping Stopped	473	489
Display or Visual Feedback Problem	236	236
Difficult to Open or Close	235	235
Device Alarm System	225	225
Pressure Problem	175	175
Mechanical Problem	166	168
Incorrect, Inadequate or Imprecise Result or Readings	124	124
Calibration Problem	117	117
Infusion or Flow Problem	113	115
Failure to Calibrate	110	110
Communication or Transmission Problem	108	109
Failure to Read Input Signal	96	96
Device Sensing Problem	96	97
Electrical /Electronic Property Problem	92	92
Power Problem	92	92
Break	68	68
Charging Problem	66	66
Battery Problem	65	66
Inadequate User Interface	58	58
No Display/Image	58	58
Failure to Pump	53	53
Application Program Problem	49	49
Failure to Power Up	43	43
Insufficient Information	42	42
Low Readings	41	42
Adverse Event Without Identified Device or Use Problem	39	39
False Alarm	33	33
No Flow	33	33
Unexpected Shutdown	33	33
Connection Problem	32	32
Crack	27	27
Unable to Obtain Readings	27	27
Defective Alarm	22	22
Decoupling	21	21
Material Deformation	21	21
Failure to Auto Stop	20	20
Mechanical Jam	20	20
Improper Flow or Infusion	19	19
Noise, Audible	19	20
Computer Software Problem	18	18
Incorrect Measurement	18	18
Increase in Pressure	15	15
Use of Device Problem	14	14
Application Program Freezes, Becomes Nonfunctional	13	13
Detachment of Device or Device Component	13	13
Overheating of Device	13	13
Circuit Failure	13	13
Loose or Intermittent Connection	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3915	3976
Insufficient Information	290	290
Cardiac Arrest	44	44
No Consequences Or Impact To Patient	27	27
No Patient Involvement	21	21
Hemorrhage/Bleeding	16	16
Air Embolism	10	10
Arrhythmia	8	8
No Known Impact Or Consequence To Patient	8	8
Low Oxygen Saturation	8	8
Low Blood Pressure/ Hypotension	7	7
Asystole	6	6
Ischemia Stroke	5	5
Brain Injury	4	4
Exsanguination	4	4
Bone Fracture(s)	4	4
Bronchial Hemorrhage	4	4
Pulmonary Edema	3	3
Hypoxia	3	3
Hemolysis	3	3
Thrombosis/Thrombus	3	3
Multiple Organ Failure	2	2
Valvular Stenosis	2	2
Nervous System Injury	2	2
Myocarditis	2	2
Ischemia	2	2
Sepsis	2	2
Septic Shock	2	2
Tachycardia	2	2
Intracranial Hemorrhage	2	2
Hemothorax	2	2
Bradycardia	2	2
Burn(s)	2	2
Hematoma	2	2
Airway Obstruction	2	2
Aneurysm	2	2
Respiratory Arrest	2	2
Cardiovascular Insufficiency	2	2
Heart Failure/Congestive Heart Failure	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Bacterial Infection	1	1
Hemolytic Anemia	1	1
Low Cardiac Output	1	1
Shock from Patient Lead(s)	1	1
Embolism/Embolus	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