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	1
APMTD, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSPIRA TECHNOLOGIES OXY B.H.N LTD.
	SUBSTANTIALLY EQUIVALENT	1
SPECTRUM MEDICAL LTD
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	265	265
Battery Problem	227	227
Power Problem	167	167
Device Alarm System	160	160
Infusion or Flow Problem	122	122
Pumping Stopped	107	107
Electrical /Electronic Property Problem	90	90
Pumping Problem	80	80
Unexpected Shutdown	70	70
Display or Visual Feedback Problem	66	66
Mechanical Problem	63	63
Noise, Audible	42	42
Obstruction of Flow	31	31
No Apparent Adverse Event	28	28
Communication or Transmission Problem	24	24
Failure to Power Up	24	24
No Display/Image	23	23
Improper or Incorrect Procedure or Method	23	23
Smoking	22	22
Decreased Pump Speed	19	19
Material Deformation	18	18
Overheating of Device	18	18
No Flow	14	14
Electrical Power Problem	13	13
Adverse Event Without Identified Device or Use Problem	9	9
Difficult to Open or Close	8	8
Incorrect, Inadequate or Imprecise Result or Readings	8	8
No Audible Alarm	8	8
Device Difficult to Setup or Prepare	7	7
Alarm Not Visible	7	7
Excessive Heating	7	7
Failure of Device to Self-Test	7	7
Increase in Pressure	6	6
Insufficient Flow or Under Infusion	6	6
Failure to Charge	6	6
Appropriate Term/Code Not Available	5	5
Failure to Interrogate	5	5
Increased Pump Speed	5	5
Complete Loss of Power	5	5
Data Problem	5	5
Detachment of Device or Device Component	4	4
Unable to Obtain Readings	4	4
Use of Device Problem	4	4
Intermittent Communication Failure	4	4
Defective Component	3	3
Nonstandard Device	3	3
Connection Problem	3	3
Decoupling	3	3
Inaccurate Flow Rate	3	3
Temperature Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1258	1258
No Consequences Or Impact To Patient	83	83
No Patient Involvement	38	38
Insufficient Information	30	30
Low Oxygen Saturation	16	16
Cardiac Arrest	10	10
Low Blood Pressure/ Hypotension	9	9
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
Dyspnea	3	3
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	1
Ischemia	1	1
Blood Loss	1	1
Multiple Organ Failure	1	1
Respiratory Acidosis	1	1
Thrombosis/Thrombus	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