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	240	240
Battery Problem	182	182
Power Problem	155	155
Pumping Stopped	147	147
Device Alarm System	146	146
Infusion or Flow Problem	132	132
Pumping Problem	79	79
Unexpected Shutdown	70	70
Mechanical Problem	69	69
Noise, Audible	67	67
Electrical /Electronic Property Problem	66	66
Display or Visual Feedback Problem	64	64
Decreased Pump Speed	53	53
Communication or Transmission Problem	53	53
Overheating of Device	45	45
No Display/Image	42	42
Obstruction of Flow	30	30
No Apparent Adverse Event	23	23
Smoking	23	23
No Flow	22	22
Appropriate Term/Code Not Available	22	22
Failure to Power Up	21	21
Electrical Power Problem	18	18
Material Deformation	16	16
Improper or Incorrect Procedure or Method	14	14
Insufficient Flow or Under Infusion	14	14
Vibration	13	13
Partial Blockage	13	13
Incorrect, Inadequate or Imprecise Result or Readings	11	11
Adverse Event Without Identified Device or Use Problem	11	11
Detachment of Device or Device Component	10	10
Connection Problem	9	9
Break	9	9
Excessive Heating	9	9
Difficult to Open or Close	8	8
Unable to Obtain Readings	7	7
No Audible Alarm	7	7
Mechanical Jam	7	7
Increased Pump Speed	6	6
Alarm Not Visible	6	6
Disconnection	6	6
Loss of Power	6	6
Nonstandard Device	6	6
Failure to Run on Battery	5	5
Failure to Charge	5	5
Temperature Problem	5	5
Device Difficult to Setup or Prepare	5	5
Complete Loss of Power	5	5
Data Problem	5	5
Failure of Device to Self-Test	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1041	1041
No Consequences Or Impact To Patient	195	195
No Known Impact Or Consequence To Patient	150	150
No Patient Involvement	139	139
Insufficient Information	27	27
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
Hypoxia	4	4
Hemorrhage/Bleeding	4	4
Stroke/CVA	3	3
Hemolysis	3	3
No Code Available	3	3
Dyspnea	3	3
Loss of consciousness	3	3
Respiratory Insufficiency	3	3
Infarction, Cerebral	2	2
Bradycardia	2	2
Asystole	2	2
Syncope/Fainting	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Complaint, Ill-Defined	1	1
Exsanguination	1	1
Ischemia	1	1
Blood Loss	1	1
Multiple Organ Failure	1	1
Thrombosis/Thrombus	1	1
Chest Pain	1	1
Cardiogenic Shock	1	1
Cardiopulmonary Arrest	1	1
Shock	1	1
Anxiety	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