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	669	669
Pumping Problem	522	533
Pumping Stopped	465	481
Display or Visual Feedback Problem	272	272
Difficult to Open or Close	254	254
Device Alarm System	232	232
Mechanical Problem	193	195
Pressure Problem	172	172
Calibration Problem	141	141
Incorrect, Inadequate or Imprecise Result or Readings	135	135
Failure to Calibrate	123	123
Infusion or Flow Problem	119	121
Communication or Transmission Problem	115	116
Electrical /Electronic Property Problem	103	103
Device Sensing Problem	96	97
Failure to Read Input Signal	95	95
Power Problem	94	94
Break	77	77
Battery Problem	75	76
Charging Problem	70	70
No Display/Image	68	68
Inadequate User Interface	63	63
Failure to Pump	62	62
Failure to Power Up	62	62
False Alarm	47	47
No Flow	44	44
Application Program Problem	42	42
Insufficient Information	39	39
Low Readings	38	39
Connection Problem	36	36
Adverse Event Without Identified Device or Use Problem	35	35
Unable to Obtain Readings	35	35
Unexpected Shutdown	34	34
Crack	25	25
Material Deformation	25	25
Mechanical Jam	24	24
Defective Alarm	23	23
Improper Flow or Infusion	22	22
Loss of or Failure to Bond	22	22
Decoupling	22	22
Noise, Audible	22	23
Application Program Freezes, Becomes Nonfunctional	21	21
Computer Software Problem	18	18
Detachment of Device or Device Component	18	18
Incorrect Measurement	18	18
Failure to Auto Stop	17	17
Increase in Pressure	15	15
Use of Device Problem	14	14
Overheating of Device	14	14
Circuit Failure	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3829	3890
No Consequences Or Impact To Patient	399	399
Insufficient Information	283	283
No Patient Involvement	204	204
No Known Impact Or Consequence To Patient	77	77
Cardiac Arrest	43	43
Hemorrhage/Bleeding	16	16
Death	11	11
Air Embolism	10	10
Low Oxygen Saturation	10	10
Arrhythmia	8	8
Low Blood Pressure/ Hypotension	7	7
Asystole	6	6
Brain Injury	4	4
Bronchial Hemorrhage	4	4
Exsanguination	4	4
Bone Fracture(s)	4	4
Hemolysis	3	3
Hypoxia	3	3
Nervous System Injury	2	2
Hemothorax	2	2
Airway Obstruction	2	2
Cardiovascular Insufficiency	2	2
Aneurysm	2	2
Tachycardia	2	2
Pulmonary Edema	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
Blood Loss	2	2
Ischemia	2	2
Hematoma	2	2
Respiratory Arrest	2	2
Sepsis	2	2
Thrombosis/Thrombus	1	1
Hemolytic Anemia	1	1
Low Cardiac Output	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
Ischemia Stroke	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