TPLC - Total Product Life Cycle

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Device	console, heart-lung machine, cardiopulmonary bypass
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
SPECTRUM MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Output Problem	733	733
Pumping Stopped	324	324
Pumping Problem	285	285
Display or Visual Feedback Problem	239	239
Mechanical Problem	196	196
Difficult to Open or Close	190	190
Device Alarm System	187	187
Incorrect, Inadequate or Imprecise Result or Readings	148	148
Failure to Calibrate	142	142
Calibration Problem	136	136
Pressure Problem	125	125
Electrical /Electronic Property Problem	122	122
Battery Problem	114	114
Communication or Transmission Problem	105	105
Charging Problem	92	92
Infusion or Flow Problem	85	85
Failure to Power Up	79	79
Break	79	79
Failure to Read Input Signal	75	75
No Display/Image	75	75
Power Problem	74	74
Appropriate Term/Code Not Available	67	67
Device Sensing Problem	67	67
Failure to Pump	65	65
Inadequate User Interface	57	57
No Flow	52	52
False Alarm	45	45
Device Displays Incorrect Message	43	43
Connection Problem	35	35
Unexpected Shutdown	33	33
Insufficient Information	32	32
Unable to Obtain Readings	31	31
Adverse Event Without Identified Device or Use Problem	30	30
Loss of or Failure to Bond	25	25
Mechanical Jam	24	24
Defective Alarm	23	23
Decoupling	23	23
Material Deformation	23	23
Noise, Audible	23	23
Erratic or Intermittent Display	20	20
Use of Device Problem	20	20
Application Program Freezes, Becomes Nonfunctional	19	19
Improper Flow or Infusion	18	18
Inaccurate Flow Rate	17	17
Detachment of Device or Device Component	16	16
Incorrect Measurement	14	14
Protective Measures Problem	13	13
Increase in Pressure	12	12
Fracture	12	12
Intermittent Communication Failure	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2663	2663
No Consequences Or Impact To Patient	844	844
No Patient Involvement	508	508
Insufficient Information	233	233
No Known Impact Or Consequence To Patient	183	183
Cardiac Arrest	37	37
Death	28	28
Air Embolism	10	10
Low Oxygen Saturation	10	10
Arrhythmia	8	8
Hemorrhage/Bleeding	8	8
Low Blood Pressure/ Hypotension	4	4
Brain Injury	4	4
Bronchial Hemorrhage	4	4
Asystole	4	4
Exsanguination	4	4
Bone Fracture(s)	4	4
Bradycardia	3	3
Blood Loss	3	3
Not Applicable	3	3
Multiple Organ Failure	2	2
Myocarditis	2	2
Ischemia	2	2
Burn(s)	2	2
Intracranial Hemorrhage	2	2
Injury	2	2
Hematoma	2	2
No Information	2	2
Valvular Stenosis	2	2
Bacterial Infection	2	2
Respiratory Arrest	2	2
Airway Obstruction	2	2
Hemothorax	2	2
Sepsis	2	2
Low Cardiac Output	1	1
Embolism/Embolus	1	1
Hemolytic Anemia	1	1
No Code Available	1	1
Shock from Patient Lead(s)	1	1
Hypoxia	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Nervous System Injury	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	LivaNova USA Inc.	III	Feb-10-2020
2	Maquet Cardiovascular Us Sales, Llc	I	Mar-28-2019
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.	I	Aug-23-2019
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
16	Terumo Cardiovascular Systems Corporation	II	Jun-11-2019
17	Terumo Cardiovascular Systems Corporation	II	May-15-2019