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
THORATEC CORPORATION (NOW PART OF ABBOTT)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Insufficient Information	332	333
Battery Problem	289	289
Power Problem	203	203
Device Alarm System	199	200
Pumping Stopped	169	171
Infusion or Flow Problem	160	162
Electrical /Electronic Property Problem	128	128
Unexpected Shutdown	104	105
Pumping Problem	98	98
Display or Visual Feedback Problem	92	92
Noise, Audible	85	87
Mechanical Problem	78	79
Communication or Transmission Problem	64	64
Decreased Pump Speed	55	55
Overheating of Device	47	47
No Display/Image	45	46
Obstruction of Flow	38	38
No Apparent Adverse Event	34	35
Improper or Incorrect Procedure or Method	28	30
Smoking	28	28
Failure to Power Up	27	27
No Flow	22	24
Appropriate Term/Code Not Available	22	23
Material Deformation	20	20
Electrical Power Problem	18	18
Insufficient Flow or Under Infusion	16	17
Use of Device Problem	14	14
Vibration	14	14
Partial Blockage	13	13
Incorrect, Inadequate or Imprecise Result or Readings	13	13
Device Difficult to Setup or Prepare	12	12
Adverse Event Without Identified Device or Use Problem	11	11
Detachment of Device or Device Component	11	11
Excessive Heating	11	11
Nonstandard Device	10	10
Break	9	9
Failure to Pump	9	9
Failure of Device to Self-Test	9	9
Connection Problem	9	9
No Audible Alarm	9	9
Failure to Interrogate	8	8
Complete Loss of Power	8	8
Difficult to Open or Close	8	10
Alarm Not Visible	7	7
Increased Pump Speed	7	7
Unable to Obtain Readings	7	7
Mechanical Jam	7	7
Failure to Charge	7	7
Increase in Pressure	6	6
Loss of Power	6	6

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	195	195
No Known Impact Or Consequence To Patient	151	151
No Patient Involvement	139	139
Insufficient Information	31	33
Low Oxygen Saturation	17	17
Cardiac Arrest	14	14
Death	12	12
Low Blood Pressure/ Hypotension	10	11
No Information	8	8
Thrombus	6	6
Hemorrhage/Bleeding	4	4
Hypoxia	4	4
Stroke/CVA	3	3
Respiratory Insufficiency	3	3
Hemolysis	3	3
No Code Available	3	4
Loss of consciousness	3	3
Thrombosis/Thrombus	3	4
Dyspnea	3	4
Asystole	2	2
Bradycardia	2	2
Infarction, Cerebral	2	2
Cardiogenic Shock	1	1
Cardiopulmonary Arrest	1	1
Chest Pain	1	1
Respiratory Acidosis	1	1
Shock	1	1
Anxiety	1	1
Cough	1	1
Unspecified Tissue Injury	1	1
Multiple Organ Failure	1	1
Cardiovascular Insufficiency	1	1
Blood Loss	1	1
Ischemia	1	1
Exsanguination	1	2
Complaint, Ill-Defined	1	1
Bacterial Infection	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Syncope/Fainting	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