TPLC - Total Product Life Cycle

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Device	control, pump speed, cardiopulmonary bypass
Regulation Description	Cardiopulmonary bypass pump speed control.
Product Code	DWA
Regulation Number	870.4380
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT (FORMERLY THORATEC CORPORATION)
	SUBSTANTIALLY EQUIVALENT	1
APMTD, INC.
	SUBSTANTIALLY EQUIVALENT	2
INSPIRA TECHNOLOGIES OXY B.H.N. , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SPECTRUM MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K192838 Quantumn Centrifugal Drive- High Pressure, Quantum ...

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	317	318
Battery Problem	282	282
Power Problem	192	192
Device Alarm System	187	188
Infusion or Flow Problem	138	140
Electrical /Electronic Property Problem	125	125
Pumping Stopped	117	119
Unexpected Shutdown	88	89
Pumping Problem	87	87
Display or Visual Feedback Problem	82	82
Mechanical Problem	68	69
Noise, Audible	52	54
Obstruction of Flow	36	36
No Apparent Adverse Event	34	35
Improper or Incorrect Procedure or Method	28	30
Communication or Transmission Problem	27	27
Failure to Power Up	26	26
No Display/Image	25	26
Smoking	25	25
Decreased Pump Speed	22	22
Overheating of Device	20	20
Material Deformation	20	20
Electrical Power Problem	15	15
No Flow	14	16
Use of Device Problem	12	12
Device Difficult to Setup or Prepare	11	11
Incorrect, Inadequate or Imprecise Result or Readings	9	9
No Audible Alarm	9	9
Adverse Event Without Identified Device or Use Problem	9	9
Excessive Heating	9	9
Failure to Interrogate	8	8
Failure to Pump	8	8
Insufficient Flow or Under Infusion	8	9
Failure of Device to Self-Test	8	8
Complete Loss of Power	8	8
Difficult to Open or Close	8	10
Alarm Not Visible	7	7
Nonstandard Device	7	7
Failure to Charge	7	7
Increase in Pressure	6	6
Increased Pump Speed	6	6
Data Problem	5	5
Appropriate Term/Code Not Available	5	6
Unable to Obtain Readings	4	4
Intermittent Communication Failure	4	4
Display Difficult to Read	4	4
Detachment of Device or Device Component	4	4
Disconnection	3	3
Temperature Problem	3	5
Loose or Intermittent Connection	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1520	1534
No Consequences Or Impact To Patient	83	83
No Patient Involvement	38	38
Insufficient Information	31	33
Low Oxygen Saturation	17	17
Cardiac Arrest	11	11
Low Blood Pressure/ Hypotension	9	10
Death	6	6
No Known Impact Or Consequence To Patient	6	6
No Information	4	4
Hypoxia	4	4
Hemorrhage/Bleeding	4	4
Hemolysis	3	3
Thrombosis/Thrombus	3	4
Dyspnea	3	4
Respiratory Insufficiency	3	3
Thrombus	3	3
Stroke/CVA	2	2
Bradycardia	2	2
Asystole	2	2
Loss of consciousness	2	2
Syncope/Fainting	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Code Available	1	1
Exsanguination	1	2
Ischemia	1	1
Blood Loss	1	1
Multiple Organ Failure	1	1
Respiratory Acidosis	1	1
Chest Pain	1	1
Cardiogenic Shock	1	1
Cardiopulmonary Arrest	1	1
Shock	1	1
Cough	1	1
Unspecified Tissue Injury	1	1
Cardiovascular Insufficiency	1	1
Bacterial Infection	1	1
Hypovolemia	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Cardiac Assist, Inc	I	Jan-19-2023
2	Cardiac Assist, Inc	I	Sep-23-2022
3	LivaNova Deutschland GmbH	III	Mar-15-2022
4	LivaNova Deutschland GmbH	II	Jul-08-2020
5	Medtronic Perfusion Systems	I	Mar-26-2021