TPLC - Total Product Life Cycle

show TPLC since

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	565	565
Pumping Problem	537	548
Pumping Stopped	502	518
Device Alarm System	245	245
Difficult to Open or Close	243	243
Display or Visual Feedback Problem	241	241
Pressure Problem	197	197
Mechanical Problem	181	183
Incorrect, Inadequate or Imprecise Result or Readings	130	130
Infusion or Flow Problem	125	127
Device Sensing Problem	123	124
Calibration Problem	123	123
Communication or Transmission Problem	112	113
Failure to Calibrate	111	111
Failure to Read Input Signal	103	103
Power Problem	99	99
Electrical /Electronic Property Problem	98	98
Battery Problem	75	76
Break	72	72
Charging Problem	72	72
Application Program Problem	61	61
Inadequate User Interface	61	61
No Display/Image	60	60
Failure to Pump	57	57
Failure to Power Up	43	43
Insufficient Information	43	43
Low Readings	43	44
Adverse Event Without Identified Device or Use Problem	39	39
Unintended Movement	39	70
False Alarm	38	38
Connection Problem	37	37
Unexpected Shutdown	36	36
No Flow	34	34
Crack	29	29
Unable to Obtain Readings	27	27
Mechanical Jam	23	23
Material Deformation	22	22
Defective Alarm	22	22
Noise, Audible	22	23
Improper Flow or Infusion	21	21
Decoupling	21	21
Failure to Auto Stop	20	20
Unstable	18	18
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
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	4236	4297
Insufficient Information	305	305
Cardiac Arrest	44	44
No Consequences Or Impact To Patient	27	27
No Patient Involvement	21	21
Hemorrhage/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
Asystole	6	6
Ischemia Stroke	5	5
Bronchial Hemorrhage	4	4
Exsanguination	4	4
Bone Fracture(s)	4	4
Hemolysis	3	3
Hypoxia	3	3
Pulmonary Edema	3	3
Thrombosis/Thrombus	3	3
Nervous System Injury	2	2
Hemothorax	2	2
Airway Obstruction	2	2
Cardiovascular Insufficiency	2	2
Aneurysm	2	2
Tachycardia	2	2
Heart Failure/Congestive Heart Failure	2	2
Bradycardia	2	2
Valvular Stenosis	2	2
Septic Shock	2	2
Intracranial Hemorrhage	2	2
Burn(s)	2	2
Myocarditis	2	2
Multiple Organ Failure	2	2
Ischemia	2	2
Hematoma	2	2
Respiratory Arrest	2	2
Sepsis	2	2
Hemolytic Anemia	1	1
Low Cardiac Output	1	1
Endocarditis	1	1
Embolism/Embolus	1	1
Bacterial Infection	1	1
Shock from Patient Lead(s)	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