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	547	547
Pumping Problem	513	524
Pumping Stopped	486	502
Display or Visual Feedback Problem	237	237
Difficult to Open or Close	236	236
Device Alarm System	233	233
Pressure Problem	182	182
Mechanical Problem	170	172
Incorrect, Inadequate or Imprecise Result or Readings	125	125
Infusion or Flow Problem	120	122
Calibration Problem	118	118
Failure to Calibrate	111	111
Communication or Transmission Problem	109	110
Device Sensing Problem	104	105
Failure to Read Input Signal	98	98
Electrical /Electronic Property Problem	95	95
Power Problem	93	93
Break	69	69
Charging Problem	67	67
Battery Problem	66	67
Inadequate User Interface	60	60
No Display/Image	59	59
Application Program Problem	55	55
Failure to Pump	54	54
Insufficient Information	43	43
Failure to Power Up	43	43
Low Readings	42	43
Adverse Event Without Identified Device or Use Problem	39	39
Unintended Movement	38	69
False Alarm	35	35
Unexpected Shutdown	34	34
No Flow	33	33
Connection Problem	32	32
Crack	28	28
Unable to Obtain Readings	27	27
Defective Alarm	22	22
Improper Flow or Infusion	21	21
Mechanical Jam	21	21
Decoupling	21	21
Material Deformation	21	21
Failure to Auto Stop	20	20
Noise, Audible	20	21
Computer Software Problem	18	18
Incorrect Measurement	18	18
Increase in Pressure	17	17
Use of Device Problem	14	14
Detachment of Device or Device Component	14	14
Unstable	14	14
Application Program Freezes, Becomes Nonfunctional	13	13
Overheating of Device	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	4050	4111
Insufficient Information	293	293
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
Low Oxygen Saturation	8	8
No Known Impact Or Consequence To Patient	8	8
Low Blood Pressure/ Hypotension	7	7
Brain Injury	6	6
Asystole	6	6
Ischemia Stroke	5	5
Bronchial Hemorrhage	4	4
Exsanguination	4	4
Bone Fracture(s)	4	4
Hypoxia	3	3
Pulmonary Edema	3	3
Thrombosis/Thrombus	3	3
Hemolysis	3	3
Burn(s)	2	2
Intracranial Hemorrhage	2	2
Myocarditis	2	2
Septic Shock	2	2
Multiple Organ Failure	2	2
Valvular Stenosis	2	2
Bradycardia	2	2
Heart Failure/Congestive Heart Failure	2	2
Ischemia	2	2
Tachycardia	2	2
Aneurysm	2	2
Hematoma	2	2
Cardiovascular Insufficiency	2	2
Respiratory Arrest	2	2
Airway Obstruction	2	2
Hemothorax	2	2
Sepsis	2	2
Nervous System Injury	2	2
Hemolytic Anemia	1	1
Low Cardiac Output	1	1
Embolism/Embolus	1	1
Shock from Patient Lead(s)	1	1
Bacterial Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	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