TPLC - Total Product Life Cycle

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Device	control, pump speed, cardiopulmonary bypass
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
THORATEC CORPORATION (NOW PART OF ABBOTT)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	258	258
Battery Problem	212	212
Power Problem	165	165
Device Alarm System	161	161
Pumping Stopped	156	156
Infusion or Flow Problem	139	139
Pumping Problem	90	90
Unexpected Shutdown	78	78
Electrical /Electronic Property Problem	77	77
Display or Visual Feedback Problem	72	72
Mechanical Problem	71	71
Noise, Audible	70	70
Communication or Transmission Problem	58	58
Decreased Pump Speed	52	52
Overheating of Device	45	45
No Display/Image	43	43
Obstruction of Flow	32	32
No Apparent Adverse Event	25	25
Failure to Power Up	23	23
Smoking	23	23
Appropriate Term/Code Not Available	22	22
Improper or Incorrect Procedure or Method	22	22
No Flow	22	22
Material Deformation	17	17
Electrical Power Problem	16	16
Insufficient Flow or Under Infusion	14	14
Partial Blockage	13	13
Vibration	13	13
Incorrect, Inadequate or Imprecise Result or Readings	12	12
Adverse Event Without Identified Device or Use Problem	11	11
Detachment of Device or Device Component	10	10
Excessive Heating	9	9
Connection Problem	9	9
Break	9	9
Failure of Device to Self-Test	8	8
Difficult to Open or Close	8	8
Mechanical Jam	7	7
Unable to Obtain Readings	7	7
No Audible Alarm	7	7
Nonstandard Device	6	6
Increase in Pressure	6	6
Loss of Power	6	6
Increased Pump Speed	6	6
Alarm Not Visible	6	6
Failure to Charge	6	6
Disconnection	6	6
Temperature Problem	5	5
Failure to Run on Battery	5	5
Device Difficult to Setup or Prepare	5	5
Complete Loss of Power	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1156	1156
No Consequences Or Impact To Patient	195	195
No Known Impact Or Consequence To Patient	150	150
No Patient Involvement	139	139
Insufficient Information	30	30
Low Oxygen Saturation	16	16
Cardiac Arrest	13	13
Death	12	12
Low Blood Pressure/ Hypotension	10	10
No Information	8	8
Thrombus	6	6
Hemorrhage/Bleeding	4	4
Hypoxia	4	4
Respiratory Insufficiency	3	3
Loss of consciousness	3	3
Dyspnea	3	3
Hemolysis	3	3
No Code Available	3	3
Stroke/CVA	3	3
Bradycardia	2	2
Asystole	2	2
Infarction, Cerebral	2	2
Respiratory Acidosis	1	1
Thrombosis/Thrombus	1	1
Blood Loss	1	1
Cardiogenic Shock	1	1
Multiple Organ Failure	1	1
Chest Pain	1	1
Cardiopulmonary Arrest	1	1
Exsanguination	1	1
Anxiety	1	1
Unspecified Tissue Injury	1	1
Shock	1	1
Cough	1	1
Ischemia	1	1
Cardiovascular Insufficiency	1	1
Bacterial Infection	1	1
Complaint, Ill-Defined	1	1
Syncope/Fainting	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	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