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	631	631
Pumping Problem	411	415
Pumping Stopped	393	397
Display or Visual Feedback Problem	241	241
Difficult to Open or Close	229	229
Device Alarm System	202	202
Mechanical Problem	180	180
Pressure Problem	139	139
Calibration Problem	135	135
Incorrect, Inadequate or Imprecise Result or Readings	124	124
Failure to Calibrate	121	121
Communication or Transmission Problem	110	110
Infusion or Flow Problem	103	103
Electrical /Electronic Property Problem	98	98
Failure to Read Input Signal	87	87
Power Problem	81	81
Device Sensing Problem	79	79
Break	74	74
Battery Problem	68	68
No Display/Image	65	65
Charging Problem	63	63
Failure to Power Up	60	60
Failure to Pump	59	59
Inadequate User Interface	57	57
False Alarm	42	42
No Flow	41	41
Insufficient Information	35	35
Unable to Obtain Readings	32	32
Adverse Event Without Identified Device or Use Problem	32	32
Unexpected Shutdown	31	31
Low Readings	30	30
Connection Problem	29	29
Material Deformation	24	24
Defective Alarm	23	23
Mechanical Jam	22	22
Loss of or Failure to Bond	22	22
Decoupling	22	22
Noise, Audible	21	21
Application Program Freezes, Becomes Nonfunctional	20	20
Improper Flow or Infusion	19	19
Computer Software Problem	17	17
Detachment of Device or Device Component	17	17
Crack	17	17
Incorrect Measurement	15	15
Increase in Pressure	14	14
Use of Device Problem	12	12
Circuit Failure	12	12
Application Program Problem	11	11
Overheating of Device	11	11
Inaccurate Flow Rate	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3313	3348
No Consequences Or Impact To Patient	399	399
Insufficient Information	261	261
No Patient Involvement	204	204
No Known Impact Or Consequence To Patient	77	77
Cardiac Arrest	38	38
Death	11	11
Low Oxygen Saturation	10	10
Air Embolism	10	10
Hemorrhage/Bleeding	10	10
Arrhythmia	8	8
Low Blood Pressure/ Hypotension	6	6
Bronchial Hemorrhage	4	4
Asystole	4	4
Bone Fracture(s)	4	4
Exsanguination	4	4
Brain Injury	4	4
Hematoma	2	2
Hemolysis	2	2
Burn(s)	2	2
Intracranial Hemorrhage	2	2
Hemothorax	2	2
Bradycardia	2	2
Bacterial Infection	2	2
Aneurysm	2	2
Blood Loss	2	2
Airway Obstruction	2	2
Nervous System Injury	2	2
Valvular Stenosis	2	2
Multiple Organ Failure	2	2
Myocarditis	2	2
Cardiovascular Insufficiency	2	2
Heart Failure/Congestive Heart Failure	2	2
Respiratory Arrest	2	2
Ischemia	2	2
Pulmonary Edema	2	2
Sepsis	2	2
Septic Shock	2	2
Tachycardia	2	2
Hypoxia	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Low Cardiac Output	1	1
Shock from Patient Lead(s)	1	1
Embolism/Embolus	1	1
Hemolytic Anemia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	LivaNova Deutschland GmbH	II	Nov-27-2024
2	LivaNova USA Inc.	III	Feb-10-2020
3	Maquet Cardiopulmonary Ag	II	May-27-2025
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
15	Terumo Cardiovascular Systems Corporation	II	Sep-12-2020
16	Terumo Cardiovascular Systems Corporation	II	Feb-07-2020