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	613	613
Pumping Stopped	367	371
Pumping Problem	353	357
Display or Visual Feedback Problem	225	225
Difficult to Open or Close	204	204
Device Alarm System	183	183
Mechanical Problem	169	169
Calibration Problem	132	132
Pressure Problem	129	129
Incorrect, Inadequate or Imprecise Result or Readings	123	123
Failure to Calibrate	119	119
Communication or Transmission Problem	107	107
Electrical /Electronic Property Problem	96	96
Infusion or Flow Problem	95	95
Failure to Read Input Signal	83	83
Power Problem	73	73
Device Sensing Problem	72	72
Break	70	70
Battery Problem	68	68
No Display/Image	64	64
Charging Problem	63	63
Failure to Power Up	60	60
Failure to Pump	58	58
Inadequate User Interface	57	57
No Flow	41	41
False Alarm	38	38
Insufficient Information	31	31
Unable to Obtain Readings	29	29
Unexpected Shutdown	27	27
Connection Problem	27	27
Adverse Event Without Identified Device or Use Problem	26	26
Low Readings	25	25
Material Deformation	24	24
Defective Alarm	23	23
Decoupling	22	22
Loss of or Failure to Bond	22	22
Mechanical Jam	20	20
Application Program Freezes, Becomes Nonfunctional	20	20
Improper Flow or Infusion	19	19
Noise, Audible	19	19
Detachment of Device or Device Component	17	17
Computer Software Problem	17	17
Incorrect Measurement	15	15
Increase in Pressure	14	14
Crack	13	13
Use of Device Problem	12	12
Circuit Failure	12	12
Failure to Charge	11	11
Overheating of Device	10	10
Insufficient Cooling	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3064	3068
No Consequences Or Impact To Patient	399	399
Insufficient Information	253	253
No Patient Involvement	204	204
No Known Impact Or Consequence To Patient	77	77
Cardiac Arrest	36	36
Death	11	11
Air Embolism	10	10
Low Oxygen Saturation	10	10
Arrhythmia	8	8
Hemorrhage/Bleeding	8	8
Low Blood Pressure/ Hypotension	4	4
Asystole	4	4
Bone Fracture(s)	4	4
Exsanguination	4	4
Bronchial Hemorrhage	4	4
Brain Injury	4	4
Ischemia	2	2
Blood Loss	2	2
Multiple Organ Failure	2	2
Hematoma	2	2
Myocarditis	2	2
Burn(s)	2	2
Intracranial Hemorrhage	2	2
Valvular Stenosis	2	2
Bradycardia	2	2
Respiratory Arrest	2	2
Tachycardia	2	2
Aneurysm	2	2
Cardiovascular Insufficiency	2	2
Bacterial Infection	2	2
Airway Obstruction	2	2
Hemothorax	2	2
Sepsis	2	2
Nervous System Injury	2	2
Embolism/Embolus	1	1
Low Cardiac Output	1	1
Hemolytic Anemia	1	1
Shock from Patient Lead(s)	1	1
Hypoxia	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	LivaNova USA Inc.	III	Feb-10-2020
3	Maquet Medical Systems USA	III	Sep-30-2024
4	Maquet Medical Systems USA	II	May-16-2024
5	Maquet Medical Systems USA	II	Feb-08-2024
6	Maquet Medical Systems USA	II	Dec-21-2023
7	Maquet Medical Systems USA	II	Dec-14-2023
8	Maquet Medical Systems USA	I	Dec-07-2023
9	Maquet Medical Systems USA	II	Nov-09-2023
10	Maquet Medical Systems USA	II	May-26-2023
11	Maquet Medical Systems USA	II	Apr-08-2022
12	Spectrum Medical Ltd.	II	Oct-24-2024
13	Terumo Cardiovascular Systems Corporation	II	Aug-26-2021
14	Terumo Cardiovascular Systems Corporation	II	Sep-12-2020
15	Terumo Cardiovascular Systems Corporation	II	Feb-07-2020